Sientra Silicone Gel Breast Implants
FDA premarket approval P070004/S009 · decided 2018-01-30
Approval details
- PMA number
- P070004
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location 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
- 2017-03-15
- Decision date
- 2018-01-30
- Days to decision
- 321 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for a manufacturing site located at 9900 Vesta, Inc., South 57th Street, Franklin, Wisconsin, a contract manufacturer.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.