MCGHAN SALINE-FILLED BREAST IMPLANT
FDA premarket approval P990074/S012 · decided 2002-08-08
Approval details
- PMA number
- P990074
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MCGHAN SALINE-FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2002-07-23
- Decision date
- 2002-08-08
- Days to decision
- 16 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR 1) DESIGN MODIFICATIONS TO THE PATCH CONFIGURATION, 2) CHANGES TO THE PATCH VULCANIZATION PROCESS, AND 3) CHANGES TO THE VALVE VULCANIZATION PROCESS.
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