FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Breast, Inflatable, Internal, Saline
PMA: P120011
·
Supplement: S016
·
Decision Jul 19, 2019
Classifications
1
FEI Numbers
9
Registration Numbers
9
Basic Information
- Device Name
- Prosthesis, Breast, Inflatable, Internal, Saline
- Trade Name
- IDEAL IMPLANT Structured Breast Implant
- PMA Number
- P120011
- Supplement Number
- S016
- 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
- July 19, 2019
- Date Received
- June 21, 2019
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Revision of grit size specification for alumina blasting media used for mandrel surface finishing from 120 to 100-120.
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 |