← FDA Medical Device Classifications
Leadless Pacemaker
PNJ · Class III — High Risk (PMA approval required, life-sustaining) · Cardiovascular · 21 CFR 870.3610
Classification
- FDA Product Code
PNJ- 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
- Y
- Implant
- Y
- Third-party review
- N
Definition
To treat bradycardia (slow heartbeats) with right atrial and/or right ventricular pacing therapy as necessary.
Market data
- Cleared 510(k) submissions
- 0
- Registered establishments
- 11
Source
- Authoritative
- FDA Device Classification database
- Machine
- JSON-LD · Markdown