← FDA Medical Device Classifications
Implantable Pacemaker Pulse-Generator
DXY · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3610
Classification
- FDA Product Code
DXY- Device class
- Class III — High Risk (PMA approval required, life-sustaining)
- Regulation
- 21 CFR 870.3610
- Review panel
- CV
- Medical specialty
- Cardiovascular
- Submission type
- 2
- GMP exempt
- N
- Life sustaining
- N
- Implant
- Y
- Third-party review
- N
Market data
- Cleared 510(k) submissions
- 461
- Registered establishments
- 27
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown