NATRELLE SALINE-FILLED BREAST IMPLANT
FDA premarket approval P990074/S018 · decided 2007-05-17
Approval details
- PMA number
- P990074
- Supplement
- S018
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NATRELLE SALINE-FILLED BREAST IMPLANT
- Generic name
- Prosthesis, breast, inflatable, internal, saline
- Applicant
- Allergan
- Date received
- 2007-02-23
- Decision date
- 2007-05-17
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- FWM
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR A TRADE NAME CHANGE FROM INAMED SALINE-FILLED BREAST IMPLANTS TO NATRELLE SALINE-FILLED BREAST IMPLANTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NATRELLE SALINE-FILLED BREAST IMPLANTS AND IS INDICATED FOR 1) BREAST AUGMENTATION FOR WOMEN 18 YEARS OR OLDER; AND 2) BREAST RECONSTRUCTION.
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