← FDA Medical Device Classifications
Replacement Heart-Valve
DYE · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3925
Classification
- FDA Product Code
DYE- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 870.3925
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Definition
Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 11
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown