Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices 65347

Food and Drug Administration

[Docket No. 95M–0397]

Progressive Angioplasty Systems,

Inc.; Premarket Approval of the PAS

LacrosseTM PTCA Catheter

AGENCY:Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Progressive Angioplasty Systems, Inc.,

Menlo Park, CA, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of the PAS

LaCrosseTM PTCA Catheter. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of September 27, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm . 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Veronica Price, Center for Devices and

Radiological Health (HFZ–450), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–443–8243.

SUPPLEMENTARY INFORMATION: On April

4, 1994, Progressive Angioplasty

Systems, Inc., Menlo Park, CA 94025–

1516, submitted to CDRH an application

for premarket approval of the PAS

LaCrosseTM PTCA Catheter. The device

is a percutaneous transluminal coronary

angioplasty (PTCA) dilatation catheter

and it is indicated for balloon dilatation

of the stenotic portion of a coronary

artery or bypass graft stenosis for the

purpose of improving myocardial

perfusion.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the Circulatory

System Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, for review and

recommendation because the

information in the PMA substantially

duplicated information previously

reviewed by this panel. On September

27, 1995, CDRH approved the

application by a letter to the applicant

from the Director of the Office of Device

Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under part 12 (21 CFR part 12)

of FDA’s administrative practices and

procedures regulations or a review of

the application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

§ 10.33(b) (21 CFR 10.33(b)). A

petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before January 18, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: December 4, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30743 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0393]

Bioetica, Inc.; Premarket Approval of

HEMOSTAGENE Absorbable

Collagen Hemostatic Sponge

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Bioetica,

Inc., Westbrook, ME, on behalf of

Coletica, S. A., Lyon, France, for

premarket approval, under the Federal

Food, Drug, and Cosmetic Act (the act),

of HEMOSTAGENE Absorbable

Collagen Hemostatic Sponge. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 15, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

ADDRESSES: Written requests for copies

of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Frances M. Curtis, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–3090.

SUPPLEMENTARY INFORMATION: On August

30, 1993, the U.S. representative,

Bioetica, Inc., Westbrook, ME 04092, on

behalf of Coletica, S. A., Lyon, France,

submitted to CDRH an application for

premarket approval of

HEMOSTAGENE Absorbable Collagen

Hemostatic Sponge. The device is an

absorbable hemostatic agent and is

indicated for use in surgical procedures

(other than in neurosurgical,

ophthalmic, and urological) as an

adjunct to hemostasis when control of

bleeding by ligature or conventional

procedures is ineffective or impractical.

In accordance with the provisions of

section 515(c)(2) of the act (21 U.S.C.

360e(c)(2)) as amended by the Safe

Medical Devices Act of 1990, this

premarket approval application (PMA)

was not referred to the General and

Plastic Surgery Devices Panel of the
65348 Federal Register / Vol. 60, No. 243 / Tuesday, December 19, 1995 / Notices

Medical Devices Advisory Committee,

an FDA advisory committee, for review

and recommendation because the

information in the PMA substantially

duplicates information previously

reviewed by this panel.

On August 15, 1995, CDRH approved

the application by a letter to the

applicant from the Director of the Office

of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act authorizes

any interested person to petition, under

section 515(g) of the act, for

administrative review of CDRH’s

decision to approve this application. A

petitioner may request either a formal

hearing under part 12 (21 CFR part 12)

of FDA’s administrative practices and

procedures regulations or a review of

the application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under

§ 10.33(b) (21 CFR 10.33(b)). A

petitioner shall identify the form of

review requested (hearing or

independent advisory committee) and

shall submit with the petition

supporting data and information

showing that there is a genuine and

substantial issue of material fact for

resolution through administrative

review. After reviewing the petition,

FDA will decide whether to grant or

deny the petition and will publish a

notice of its decision in the Federal

Register. If FDA grants the petition, the

notice will state the issue to be

reviewed, the form of the review to be

used, the persons who may participate

in the review, the time and place where

the review will occur, and other details.

Petitioners may, at any time on or

before January 18, 1996, file with the

Dockets Management Branch (address

above) two copies of each petition and

supporting data and information,

identified with the name of the device

and the docket number found in

brackets in the heading of this

document. Received petitions may be

seen in the office above between 9 a.m.

and 4 p.m., Monday through Friday.

This notice is issued under the

Federal Food, Drug, and Cosmetic Act

(secs. 515(d), 520(h) (21 U.S.C. 360e(d),

360j(h))) and under authority delegated

to the Commissioner of Food and Drugs

(21 CFR 5.10) and redelegated to the

Director, Center for Devices and

Radiological Health (21 CFR 5.53).

Dated: November 29, 1995.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 95–30697 Filed 12–18–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95M–0398]

Cochlear Corp.; Premarket Approval of

New Indication for Use for the Nucleus

22–Channel Cochlear Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the supplemental

application by Cochlear Corp.,

Englewood, CO, for premarket approval,

under section 515 of the Federal Food,

Drug, and Cosmetic Act (the act), of a

new indication for use for the Nucleus

22–Channel Cochlear Implant. FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of August 21, 1995, of the

approval of the application.

DATES: Petitions for administrative

review by January 18, 1996.

ADDRESSES: Address written requests for

copies of the summary of safety and

effectiveness data and petitions for

administrative review to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 12420

Parklawn Dr., rm. 1–23, Rockville, MD

20857.

FOR FURTHER INFORMATION CONTACT:

Marilyn Flack, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On August

8, 1992, Cochlear Corp., Englewood, CO

80112, submitted to CDRH a

supplemental application for premarket

approval of an expanded indication for

use for the Nucleus 22–Channel

Cochlear Implant. The device was

originally approved in 1985 for use in

adults who demonstrated postlinguistic,

bilateral, sensorineural hearing loss and

obtained little or no benefit from

conventional amplification. It was

approved in 1990 for use in children

who demonstrated bilateral, profound,

sensorineural hearing loss and obtained

little or no benefit from conventional

amplification or vibrotactile hearing

aids. The expanded indication for use

now includes patients, 18 years and

older, who have bilateral, postlinguistic,

sensorineural hearing impairment and

obtain limited benefit from appropriate

binaural hearing aids. Limited benefit

from amplification is defined by test

scores of 30 percent correct or less in

the best-aided listening condition on

tape-recorded tests of open-set sentence

recognition. These patients typically

have low frequency residual hearing in

the moderate-to-profound range and

profound (greater than or equal to 90

dBHL) hearing loss in the mid-to-high

speech frequencies.

On April 20, 1995, the Ear, Nose and

Throat Devices Advisory Panel, an FDA

advisory panel, reviewed and

recommended approval of the

supplemental application.

On August 21, 1995, CDRH approved

the supplemental application by a letter

to the applicant from the Director of the

Office of Device Evaluation, CDRH.

A summary of the safety and

effectiveness data on which CDRH

based its approval is on file in the

Dockets Management Branch (address

above) and is available from that office

upon written request. Requests should

be identified with the name of the

device and the docket number found in

brackets in the heading of this

document.

Opportunity for Administrative Review

Section 515(d)(3) of the act (21 U.S.C.

360e(d)(3)) authorizes any interested

person to petition, under section 515(g)

of the act (21 U.S.C. 360e(g)), for

administrative review of CDRH’s

decision to approve this supplemental

application. A petitioner may request

either a formal hearing under part 12 (21

CFR part 12) of FDA’s administrative

practices and procedures regulations or

a review of the supplemental

application and CDRH’s action by an

independent advisory committee of

experts. A petition is to be in the form

of a petition for reconsideration under §

10.33(b) (21 CFR 10.33(b)). A petitioner

shall identify the form of review

requested (hearing or independent

advisory committee) and shall submit

with the petition supporting data and

information showing that there is a

genuine and substantial issue of

material fact for resolution through

administrative review. After reviewing

the petition, FDA will decide whether to

grant or deny the petition and will

publish a notice of its decision in the

Federal Register. If FDA grants the

petition, the notice will state the issue

to be reviewed, the form of the review

to be used, the persons who may

participate in the review, the time and