49692 Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices

Dated: September 17, 1997.

Wilma G. Johnson,

Acting Associate Director for Policy Planning

And Evaluation, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 97–25170 Filed 9–22–97; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0396]

Advanced BionicsTM Corp.; Premarket

Approval of CLARION MultiStrategyTM Cochlear Implant

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by

Advanced BionicsTM Corp., Sylmar, CA,

for premarket approval, under the

Federal Food, Drug, and Cosmetic Act

(the act), of the CLARION MultiStrategyTM Cochlear Implant. After

reviewing the recommendation of the

Ear, Nose, and Throat Devices Panel,

FDA’s Center for Devices and

Radiological Health (CDRH) notified the

applicant, by letter of June 26, 1997, of

the approval of the application.

DATES: Petitions for administrative

review by October 23, 1997.

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: I.

Sidney Jaffee, Center for Devices and

Radiological Health (HFZ–470), Food

and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2080.

SUPPLEMENTARY INFORMATION: On

December 29, 1996, Advanced

BionicsTM Corp., Sylmar, CA 91342,

submitted to CDRH an application for

premarket approval of the CLARION

Multi-StrategyTM Cochlear Implant. The

device is a cochlear implant and is

intended to restore a level of auditory

sensation to individuals with profound

sensorineural deafness via electrical

stimulation of the auditory nerve. The

CLARION Multi-StrategyTM Cochlear

Implant is indicated for the following:

Children:

• Two through 17 years of age. If xrays demonstrate evidence of

ossification, children as young as 18

months may be implanted;

• Profound, bilateral sensorineural

deafness (≥90 dB);

• Undergone or be willing to

undergo a hearing aid trial with

appropriately fitted hearing aids; and

• Lack of benefit from appropriately

fitted hearing aids. In younger children,

lack of benefit with hearing aids is

defined as a failure to attain basic

auditory milestones such as a child’s

inconsistent response to his/her name in

quiet or to environmental sounds

(Meaningful Auditory Integration Scale).

In older children, lack of aided benefit

is defined as scoring 0 percent on openset word recognition (Phonetically

Balanced Kindergarten Test—Word List)

administered with monitored live-voice

(70 dB SPL). Both younger and older

children should demonstrate only

minimal ability on age appropriate

open-set sentence measures and a

plateau in auditory development.

On May 21, 1997, the Ear, Nose, and

Throat Devices Panel of the Medical

Devices Advisory Committee, an FDA

advisory committee, reviewed and

recommended approval of the

application. On June 26, 1997, CDRH

approved the application by a letter to

the applicant from the Deputy Director

of Clinical and Policy Review 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, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 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 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 October 23, 1997, 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: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25163 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0393]

Avanta Orthopaedics Corp.; Premarket

Approval of Braun-Cutter Trapezometacarpal prosthesis

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the application by Avanta

Orthopaedics Corp., San Diego, CA, for

premarket approval, under the Federal

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

of the Braun-Cutter Trapezo-metacarpal

Prosthesis. After reviewing the

recommendation of the Orthopedics and

Rehabilitation Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 19, 1997, of the

approval of the application.

DATES: Petitions for administrative

review by October 23, 1997.
Federal Register / Vol. 62, No. 184 / Tuesday, September 23, 1997 / Notices 49693

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:

Theodore R. Stevens, Center for Devices

and Radiological Health (HFZ–410),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–2036.

SUPPLEMENTARY INFORMATION: On

December 24, 1996, Avanta

Orthopaedics Corp., San Diego, CA

92121, submitted to CDRH an

application for premarket approval of

the Braun-Cutter Trapezo-metacarpal

Prosthesis. The device is a finger joint

metal/polymer cemented prosthesis and

is indicated for total joint replacement

in skeletally mature patients with pain

or instability of the trapezo-metacarpal

joint due to trauma, inflammatory or

degenerative disease or revision of

previous procedures, as an alternative to

arthrodesis or reconstructive surgery.

On June 9, 1997, the Orthopedics and

Rehabilitation Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

application. On June 19, 1997, 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 Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 360e(d)(3)) 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 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

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 October 23, 1997, 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: August 26, 1997.

Joseph A. Levitt,

Deputy Director for Regulations Policy, Center

for Devices and Radiological Health.

[FR Doc. 97–25127 Filed 9–22–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97M–0392]

Mallinckrodt, Inc.; Premarket Approval

of Albunex

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing its

approval of the supplemental

application by Mallinckrodt, Inc., St.

Louis, MO, for premarket approval,

under the Federal Food, Drug, and

Cosmetic Act (the act), of Albunex .

After reviewing the recommendation of

the Radiological Devices Panel, FDA’s

Center for Devices and Radiological

Health (CDRH) notified the applicant,

by letter of June 17, 1997, of the

approval of the supplemental

application.

DATES: Petitions for administrative

review by October 23, 1997.

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:

Robert A. Phillips, Center for Devices

and Radiological Health (HFZ–470),

Food and Drug Administration, 9200

Corporate Blvd., Rockville, MD 20850,

301–594–1212.

SUPPLEMENTARY INFORMATION: On

September 3, 1995, Mallinckrodt, Inc.,

St. Louis, MO 63134, submitted to

CDRH a supplemental application for

premarket approval of Albunex . The

device is an ultrasound contrast agent

and is indicated for use with

transvaginal ultrasound to assess

fallopian tube patency.

On February 24, 1997, the

Radiological Devices Panel of the

Medical Devices Advisory Committee,

an FDA advisory committee, reviewed

and recommended approval of the

supplemental application. On June 17,

1997, CDRH approved the supplemental

application by a letter to the applicant

from the Deputy Director of Clinical and

Review Policy 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, for administrative review of

CDRH’s decision to approve this

application. A petitioner may request

either a formal hearing under 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 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