MCGHAN SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990074/S005 · decided 2001-04-09
Approval details
- PMA number
- P990074
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MCGHAN SALINE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2001-01-29
- Decision date
- 2001-04-09
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A NEW SERIES OF SIZES FOR THE STYLE 363 SALINE-FILLED BREAST IMPLANT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLE 363LF AND IS INDICATED FOR: 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER AND 2) BREAST RECONSTRUCTION.
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