Sientra Silicone Gel Breast Implants
FDA premarket approval P070004/S011 · decided 2017-11-30
Approval details
- PMA number
- P070004
- Supplement
- S011
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Sientra Silicone Gel Breast Implants
- Generic name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Applicant
- Tiger Aesthetics Medical, LLC
- Date received
- 2017-11-06
- Decision date
- 2017-11-30
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Approval for changes to the labeling including modifications to the language in the physician and patient labeling regarding the potential risk of breast implant associated anaplastic large cell lymphoma (BIA-ALCL).
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