Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
MPCClass III

Atrial Defibrillator

21 CFR 870.5300 / Cardiovascular

MPC is the FDA product code for Atrial Defibrillator, a class III device type, regulated under 21 CFR 870.5300. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
MPC
Device name
Atrial Defibrillator
FDA 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.
Regulation
21 CFR 870.5300
Device class
Class III
Review panel
Cardiovascular
Submission type
PMA
Implant
Yes
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code MPC.