← FDA Medical Device Classifications
Pulmonic Replacement Heart Valve
PAL · f · Cardiovascular · 21 CFR 870.3925
Classification
- FDA Product Code
PAL- Device class
- f
- Regulation
- 21 CFR 870.3925
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 6
- GMP exempt
- N
- Life sustaining
- Y
- Implant
- Y
- Third-party review
- N
Definition
For open surgical replacement of malfunctioning pulmonic heart valve.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 0
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown