FDA product code MRM: Defibrillator, Implantable, Dual-Chamber

MRM is the FDA product code for defibrillator, implantable, dual-chamber. It is a Class III device, reviewed by the Cardiovascular panel. Devices under MRM reach the market by PMA; FDA lists no cleared 510(k)s for it. 3 PMA applications cite this product code. FDA has posted 34 recalls for MRM devices.

Classification

Recalls for MRM devices

34 product recalls in 7 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2021-03-08.

HCPCS codes with matching descriptors

Text match between the FDA device name and CMS descriptors, not an official crosswalk:

• C7540 — Removal of permanent pacemaker pulse generator with replacement of pacemaker pulse generator, dual lead system, with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
• C7538 — Insertion of new or replacement of permanent pacemaker with ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)
• C7539 — Insertion of new or replacement of permanent pacemaker with atrial and ventricular transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (eg, for upgrade to dual chamber system)
• C7537 — Insertion of new or replacement of permanent pacemaker with atrial transvenous electrode(s), with insertion of pacing electrode, cardiac venous system, for left ventricular pacing, at time of insertion of implantable defibrillator or pacemaker pulse generator (e.g., for upgrade to dual chamber system)

Frequently asked questions

What is FDA product code MRM?

MRM is the FDA product code for defibrillator, implantable, dual-chamber. It is a Class III device, reviewed by the Cardiovascular panel.

What device class is MRM?

Class III. Typical premarket route: PMA.

Have MRM devices been recalled?

Yes: 34 product recalls across 7 recall events; the most recent began 2021-03-08.

Next steps

• Run an FDA pathway report with predicate devices for product code MRM
• Run a recall and safety report across every MRM manufacturer
• Watch product code MRM for new clearances and recalls

Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.

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