MCGHAN SALINE-FILLED BREAST IMPLANTS
FDA premarket approval P990074/S014 · decided 2003-03-12
Approval details
- PMA number
- P990074
- Supplement
- S014
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MCGHAN SALINE-FILLED BREAST IMPLANTS
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2003-02-13
- Decision date
- 2003-03-12
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL TO MANUFACTURE MCGHAN SALINE-FILLED BREAST IMPLANTS, STYLES 168, 163, 363LF, AND 468 AT INAMED CORPORATION'S FACILITY LOCATED IN BARREAL DE HEREDIA, COSTA RICA.
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| Natrelle 133S Tissue Expander (K182054) | Allergan | 2018-08-29 |
| TrueTear Intranasal Tear Neurostimulator (DEN170086) | Allergan | 2018-05-17 |
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