Sientra OPUS® Silicone Gel Breast Implants
FDA premarket approval P070004/S037 · decided 2022-07-20
Approval details
- PMA number
- P070004
- Supplement
- S037
- 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
- 2022-06-17
- Decision date
- 2022-07-20
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- FTR
- Advisory committee
- General, Plastic Surgery
- Expedited review
- No
- Location
- Franklin, WI
- Statement
- Changes to the environmental monitoring plan for both viable and non-viable particulates in Sientras manufacturing cleanroom, located in Franklin, Wisconsin.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.