FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Breast, Inflatable, Internal, Saline
PMA: P120011
·
Supplement: S004
·
Decision May 11, 2016
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Prosthesis, Breast, Inflatable, Internal, Saline
- Trade Name
- IDEAL IMPLANT SALINE-FILLED BREAST IMPLANT
- PMA Number
- P120011
- Supplement Number
- S004
- Device Class
- FDA Class 3
- Product Code
- FWM
- Generic Name
- Prosthesis, breast, inflatable, internal, saline
- Regulation Number
- 878.3530
- Medical Specialty
- General, Plastic Surgery
- Advisory Committee
- General, Plastic Surgery
- Decision
- 30-Day Notice Accepted
- Decision Code
- OK30
- Decision Date
- May 11, 2016
- Date Received
- April 15, 2016
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Replacement of dry heat sterilization temperature sensors from pyrobuttons to thermocouples and added digital temperature chart printout, located in Specialty Silicone Fabricators (SSF), 2761 Walnut Avenue, Tustin, California, 92780.
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 |
|---|---|---|---|
| FWM | Prosthesis, Breast, Inflatable, Internal, Saline | FDA class 3 | General, Plastic Surgery |