FDA PMA
FDA Class 3
30-Day Notice Accepted
🇺🇸 United States
Prosthesis, Breast, Inflatable, Internal, Saline
PMA: P120011
·
Supplement: S011
·
Decision Jun 28, 2018
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
- S011
- 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
- June 28, 2018
- Date Received
- June 8, 2018
- Supplement Type
- 30-Day Notice
- Supplement Reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Expedited Review
- N
Advisory Committee Statement
Change to the bubble specification for the inner and outer shell to increase the allowable number of microscopic bubbles less than or equal to 0.020 inches in size from 5 bubbles to 10 bubbles.
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 |