Sientra OPUS Silicone Gel Breast Implants
FDA premarket approval P070004/S014 · decided 2018-01-19
Approval details
- PMA number
- P070004
- Supplement
- S014
- Supplement type
- 30-Day Notice
- 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
- 2017-12-21
- Decision date
- 2018-01-19
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Changes to sterilization equipment and dry heat sterilization cycle, and packaging features for Sientra OPUS Silicone Gel Breast Implants at the following manufacturing facility: Vesta, Inc., 9900 South 57th Street, Franklin, Wisconsin.
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