Product code MPC
- Device name
- Atrial Defibrillator
- Medical specialty
- Cardiovascular
- Device class
- 3
- Regulation number
- 870.5300
- Review panel
- CV
- Implant
- Y
- Life sustaining/supporting
- Y
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Ineligible
- Definition
- Call for PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients who are icd indicated and who have atrial tachyarrhythmias, or who are at risk of developing atrial tachyarrhythmias.
- Source
- FDA openFDA device classification dataset