SIENTRA SILICONE GEL BREAST IMPLANTS
FDA premarket approval P070004/S004 · decided 2012-06-07
Approval details
- PMA number
- P070004
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Trade name
- SIENTRA SILICONE GEL BREAST IMPLANTS
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2012-04-09
- Decision date
- 2012-06-07
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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