← FDA Medical Device Classifications
Prosthesis, Breast, Inflatable, Internal, Saline
FWM · Class III — High Risk (PMA approval required, life-sustaining) · General, Plastic Surgery · 21 CFR 878.3530
Classification
- FDA Product Code
FWM- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 878.3530
- Review panel
- SU
- Medical specialty
- General, Plastic Surgery
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for PMAs to be filed by 11/17/99 per 64 FR 45161 on 8/19/99
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 8
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown