Sientra OPUS Silicone Gel Breast Implants
FDA premarket approval P070004/S016 · decided 2023-01-03
Approval details
- PMA number
- P070004
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- Sientra OPUS Silicone Gel Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2019-01-18
- Decision date
- 2023-01-03
- Days to decision
- 1446 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for revisions to the labeling to include the 10 year clinical study results.
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