# Leadless Pacemaker
> **Product code: 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
- [FDA Device Classification](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/classification.cfm?ID=PNJ)
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