← FDA Medical Device Classifications
Aortic Heart Valve, More Than Minimally Manipulated Allograft
PAP · f · Unknown
Classification
- FDA Product Code
PAP- Device class
- f
- Regulation
- —
- Review panel
- CV
- Medical specialty
- Unknown
- Submission type
- 6
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- Y
- Third-party review
- N
Definition
Intended for use in the replacement of diseased, damaged, malformed, or malfunctioning native or prosthetic aortic valves in pediatric patients.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown