Sientra Silicone Gel Breast Implants
FDA premarket approval P070004/S036 · decided 2022-10-06
Approval details
- PMA number
- P070004
- Supplement
- S036
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sientra Silicone Gel Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2022-05-11
- Decision date
- 2022-10-06
- Days to decision
- 148 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for a trade name change from Sientra OPUS Silicone Gel Breast Implants to Sientra Silicone Gel Breast Implants.
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