FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
PMA: P070004
·
Supplement: S013
·
Decision Apr 17, 2018
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
- Trade Name
- Sientra OPUS Silicone Gel Breast Implants
- PMA Number
- P070004
- Supplement Number
- S013
- Device Class
- FDA Class 3
- Product Code
- FTR
- Generic Name
- Prosthesis, breast, noninflatable, internal, silicone gel-filled
- Regulation Number
- 878.3540
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- April 17, 2018
- Date Received
- December 14, 2017
- Supplement Type
- 135 Review Track For 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Approval for dimethyl silicone dispersion solvent from perchloroethylene to xylene.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FTR | Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled | FDA class 3 | General, Plastic Surgery |