MPC — Atrial Defibrillator Class III
FDA product code MPC covers "Atrial Defibrillator", a Class III medical device regulated under 21 CFR 870.5300. Submissions are reviewed by the Cardiovascular panel. Devices under this code are implants.
Classification Details
- Product Code
- MPC
- Device Class
- Class III
- Regulation Number
- 870.5300
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- Yes
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.