SIENTRA SILICONE GEL BREAST IMPLANTS
FDA premarket approval P070004/S007 · decided 2014-01-08
Approval details
- PMA number
- P070004
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2013-12-12
- Decision date
- 2014-01-08
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- CHANGES TO THE MATERIAL OF THE BREAST IMPLANT MOLDS.
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