Sientra OPUS Silicone Gel Breast Implants
FDA premarket approval P070004/S035 · decided 2022-07-05
Approval details
- PMA number
- P070004
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Sientra OPUS Silicone Gel Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2022-04-08
- Decision date
- 2022-07-05
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for the Low Profile Plus projection style to the current portfolio of Sientra Silicone Gel Breast Implants.
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