17136 Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 

13. Endolymphatic Shunt Tube with 

Valve, 

14. Hip Joint Metal/Polymer 

Constrained Cemented or Uncemented 

Prosthesis, 

15. Apnea Monitors, 

16. Polymethylmethacrylate (PMMA) 

Bone Cement, 

17. Cyclosporine and Tacrolimus 

Assays, 

18. Transcutaneous Air Conduction 

Hearing Aid System (TACHAS), 

19. Intraoral Devices for Snoring and/ 

or Obstructive Sleep Apnea, 

20. Cutaneous Carbon Dioxide and 

Oxygen Monitors, 

21. Knee Joint Patellofemorotibial and 

Femorotibial Metal/Polymer PorousCoated Uncemented Prostheses, 

22. Optical Impression Systems for 

Computer Assisted Design and 

Manufacturing (CAD/CAM) of Dental 

Restorations, 

23. Resorbable Calcium Salt Bone 

Void Filler Device, 

24. Surgical Sutures, 

25. Breath Nitric Oxide Test, 

26. Breast Lesion Documentation 

System, 

27. Arrhythmia Detector and Alarm, 

28. Serological Reagents for the 

Laboratory Diagnosis of West Nile Virus, 

29. Endotoxin Assay, 

30. Dental Sonography and Jaw 

Tracking Devices, 

31. Human Dura Mater (applicable to 

dura mater recovered before May 25, 

2005), 

32. Hepatitis A Virus Serological 

Assays, 

33. Factor V Leiden DNA Mutation 

Detection Systems, 

34. Immunomagnetic Circulating 

Cancer Cell Selection and Enumeration 

System, 

35. Root-form Dental Implants and 

Endosseous Dental Implant Abutments, 

36. Dental Base Metal Alloys, 

37. Dental Noble Metal Alloys, 

38. Serological Assays for the 

Detection of Beta-Glucan, 

39. Sirolimus Test Systems, 

40. Newborn Screening Test Systems 

for Amino Acids, Free Carnitine, and 

Acylcarnitines Using Tandem Mass 

Spectrometry, 

41. Implantable Radiofrequency 

Transponder System for Patient 

Identification and Health Information, 

42. External Penile Rigidity Devices, 

43. Assisted Reproduction Laser 

Systems, 

44. Vascular and Neurovascular 

Embolization Devices, 

45. Drug Metabolizing Enzyme 

Genotyping System, 

46. Instrumentation for Clinical 

Multiplex Test Systems, 

47. Automated Fluorescence in situ 

Hybridization (FISH) Enumeration 

Systems, 

48. Dental Bone Grafting Material 

Devices, 

49. RNA Preanalytical Systems (RNA 

Collection, Stabilization and 

Purification Systems for RT–PCR used 

in Molecular Diagnostic Testing), 

50. Oral Rinse to Reduce the 

Adhesion of Dental Plaque, 

51. AFP–L3% Immunological Test 

Systems, 

52. CFTR Gene Mutation Detection 

System, 

53. Low Energy Ultrasound Wound 

Cleaner, 

54. Tinnitus Masker Devices, 

55. Labeling for Male Condoms Made 

of Natural Rubber Latex, 

56. Implantable Intra-Aneurysm 

Pressure Measurement System, 

57. Reagents for Detection of Specific 

Novel Influenza A Viruses, 

58. Topical Oxygen Chamber for 

Extremities, 

59. Olfactory Test Device, 

60. Fecal Calprotectin Immunological 

Test Systems, 

61. Absorbable Hemostatic Device, 

62. Quality Control Material for Cystic 

Fibrosis Nucleic Acid Assays, 

63. Oxygen Pressure Regulators and 

Oxygen Conserving Devices, 

64. Herpes Simplex Virus Types 1 and 

2 Serological Assays, 

65. Computerized Labor Monitoring 

Systems, 

66. Gene Expression Profiling Test 

System for Breast Cancer Prognosis, 

67. Intervertebral Body Fusion Device, 

68. Filtering Facepiece Respirator for 

Use by the General Public in Public 

Health Medical Emergencies, 

69. Absorbable Poly(hydroxybutyrate) 

Surgical Suture Produced by 

Recombinant DNA Technology, 

70. In Vitro Human 

Immunodeficiency Virus (HIV) Drug 

Resistance Genotype Assay, 

71. Electrocardiograph Electrodes, 

72. Remote Medication Management 

System, 

73. Automated Blood Cell Separator 

Device Operating by Centrifugal or 

Filtration Separation Principle, 

74. Plasmodium Species Antigen 

Detection Assays, 

75. Full Field Digital Mammography 

System, 

76. Certain Percutaneous 

Transluminal Coronary Angioplasty 

(PTCA) Catheters, 

77. Tissue Adhesive for the Topical 

Approximation of Skin, 

78. Bone Sonometers, 

79. Tissue Expander, 

80. Cord Blood Processing System and 

Storage Container. 

II. Electronic Access 

Persons interested in obtaining a copy 

of any revised special controls guidance 

document may do so by using the 

Internet. A search capability for all 

CDRH guidance documents is available 

at http://www.fda.gov/MedicalDevices/

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. To 

receive any affected CDRH guidance you 

may either send an email request to 

dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 301–847–8149 to receive 

a hard copy. 

For CBER guidances, you may send a 

request to the Office of Communication, 

Outreach and Development (HFM–40), 

Center for Biologics Evaluation and 

Research (CBER), Food and Drug 

Administration, 1401 Rockville Pike, 

suite 200N, Rockville, MD 20852–1448. 

The guidance may also be obtained by 

mail by calling CBER at 1–800–835– 

4709 or 301–827–1800. In addition, 

CBER guidance documents are available 

at http://www.fda.gov/Biologics

BloodVaccines/GuidanceCompliance

RegulatoryInformation/default.htm. 

III. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed comments. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

Authority: 21 U.S.C. 371(h). 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7211 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–M–0519, FDA– 

2010–M–0556, FDA–2010–M–0558, FDA– 

2010–M–0557, and FDA–2010–M–0591] 

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 


Emcdonald on DSK2BSOYB1PROD with NOTICES
Federal Register / Vol. 76, No. 59 / Monday, March 28, 2011 / Notices 17137 

(PMAs) to inform the public of the 

availability of safety and effectiveness 

summaries of approved PMAs through 

the Internet and the Agency’s Division 

of Dockets Management. 

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness data to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Please cite the appropriate docket 

number as listed in table 1 of this 

document when submitting a written 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the summaries of safety and 

effectiveness. 

FOR FURTHER INFORMATION CONTACT: 

Nicole Wolanski, Center for Devices and 

Radiological Health, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 66, rm. 1650, Silver Spring, 

MD 20993, 301–796–6570. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the Agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register. 

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

Cosmetic Act (the FD&C Act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the FD&C 

Act. The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from October 1, 2010, through 

December 31, 2010, and includes one 

denial action during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the date of action. 

TABLE 1—LIST OF PMA ACTIVITY FROM OCTOBER 1, 2010, THROUGH DECEMBER 31, 2010 

PMA No. Docket No. Applicant Trade name Date of action 

P100016 ................... FDA–2010–M–0556 Aaren Scientific, Inc EC–3 intraocular lens (IOL) and EC–3 

precision aspheric lens (PAL) IOL.

Approved October 19, 2010. 

P040005 (S005) ....... FDA–2010–M–0558 Dako Denmark A/S HER 2 FISH PharmDx kit ........................ Approved October 20, 2010. 

P980018 (S010) ....... FDA–2010–M–0557 Dako Denmark A/S HercepTest kit .......................................... Approved October 20, 2010. 

P080009 ................... ................................. Ethicon Endo-Surgery, Inc.SEDASYS computer-assisted personalized sedation system.Denied October 27, 2010. 

P080018 ................... FDA–2010–M–0591 Carestream Health, 

Inc.

Kodak DirectView CR mammography 

system.

Approved November 3, 2010. 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7212 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0002] 

Pregnancy and Prescription 

Medication Use Symposium 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

meeting: Pregnancy and Prescription 

Medication Use Symposium. The topic 

to be discussed is ‘‘Prescription Drug 

Use in Pregnancy.’’ 

Date and Time: The meeting will be 

held on May 17, 2011, from 8 a.m. to 

4:30 p.m. 

Location: The meeting will be held at 

FDA White Oak Campus, 10903 New 

Hampshire Ave., Building 31 

Conference Center, the Great Room (rm. 

1503), Silver Spring, MD 20993–0002. 

Contact: Monica Yu, Office of 

Women’s Health (OWH), Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 2313, 301–796–9449, 

e-mail: monica.yu@fda.hhs.gov. 

Registration: There is no registration 

fee, but seating is limited to 100. Send 

registration information (including 

name, title, firm name, address, 

telephone number, and e-mail address), 

to the following registration link by May 

10, 2011: http:// 

www.accessdata.fda.gov/scripts/email/ 

oc/pregnancysymposium.cfm. 

If you need special accommodations 

due to a disability, please contact 

Monica Yu at least 7 days in advance. 

Visitor parking: Please see http:// 

www.fda.gov/AboutFDA/ 

WorkingatFDA/BuildingsandFacilities/ 

WhiteOakCampusInformation/ 

ucm241740.htm. 

SUPPLEMENTARY INFORMATION: 

Transcripts: There will not be any 

transcripts; however, the speakers’ 

Power Point presentations will be 

posted on the FDA/OWH Web site after 

the meeting at: http://www.fda.gov/ 

ForConsumers/byAudience/ForWomen/ 

default.htm. 

Dated: March 23, 2011. 

David Dorsey, 

Acting Deputy Commissioner for Policy, 

Planning and Budget. 

[FR Doc. 2011–7215 Filed 3–25–11; 8:45 am] 

BILLING CODE 4160–01–P 


Emcdonald on DSK2BSOYB1PROD with NOTICES