United States Government Publishing Office
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United States
National Archives and Records Administration
Office of the Federal Register
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FR
Regulatory Information
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2017-01-09
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General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Inflatable (Saline- Filled) Breast Prosthesis; Public Hearing
UNKNOWN
D09002ee1be071c50
United States
Department of Health and Human Services
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United States Government Agency or Subagency
The Food and Drug Administration (FDA) is announcing a public hearing on a proposed rule to amend its regulations to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the silicone inflatable (saline-filled) breast prosthesis, a medical device. The purpose of the public hearing is to assist the agency in determining when to issue a final rule to require the filing of a PMA for the silicone inflatable breast prosthesis.
59 FR 0
https://www.govinfo.gov/app/details/FR-1994-05-04/94-10785
94-10785
fr04my94-24
4160-01-F
Federal Register: May 4, 1994
Docket No. 91N-0281
https://www.govinfo.gov/app/details/FR-1994-05-04/94-10785
https://www.govinfo.gov/content/pkg/FR-1994-05-04/html/94-10785.htm
1 p.
0
0
59 FR 0
Code of Federal Regulations
Title 21 Part 878
21 CFR Part 878
General and Plastic Surgery Devices; Effective Date of Requirement for Premarket Approval of Silicone Inflatable (Saline- Filled) Breast Prosthesis; Public Hearing; Federal Register Vol. 59, Issue
UNKNOWN
94-10785
DEPARTMENT OF HEALTH AND HUMAN SERVICES
1994-07-05
1994-06-02
Federal Register: May 4, 1994
Docket No. 91N-0281
4160-01-F
94-10785
Notice of public hearing.
The Food and Drug Administration (FDA) is announcing a public hearing on a proposed rule to amend its regulations to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the silicone inflatable (saline-filled) breast prosthesis, a medical device. The purpose of the public hearing is to assist the agency in determining when to issue a final rule to require the filing of a PMA for the silicone inflatable breast prosthesis.
The public hearing will be held on Thursday, June 2, 1994, from 9 a.m. to 6 p.m. Submit written notices of participation and comments by May 16, 1994. Written comments will be accepted until July 5, 1994.
Thomas Arrowsmith-Lowe, Office of Health Affairs (HFY-40), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-443-1472.
Federal Register
Vol. 59, no. 85
Office of the Federal Register, National Archives and Records Administration
1994-05-04
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188 p.
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