FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled
PMA: P070004
·
Supplement: S010
·
Decision Dec 1, 2017
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
- S010
- 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
- December 1, 2017
- Date Received
- June 5, 2017
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
Approval for a trade name change from Sientra Silicone Gel Breast Implants to Sientra OPUS Silicone Gel Breast Implants.
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 |