PMA P820003

Device: Versatrax Model 7000 Universal A-V Pulse Generator
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P820003
Supplement: S139
Product code: LWP
Decision date: 2025-03-20
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Approval order statement: approval for a predetermined change control plan (PCCP) that encompasses the following biocompatibility-related manufacturing changes, provided that they do not impact the properties of the device materials, for the devices under the above PMAs:1. Removal of a processing aid (solvent, lubricant, antifoaming agent, etc.), or cleaning agent2. Removal of a cleaning process3. Change in parameters (temperature, time, sonication, etc.) of a current cleaning process

Current openFDA PMA Record#

Device: Versatrax Model 7000 Universal A-V Pulse Generator
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P820003
Supplement: S144
Product code: LWP
Generic name: Implantable pulse generator, pacemaker (non-CRT)
Decision date: 2025-03-20
Decision code: APPR
Date received: 2025-02-13
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for a predetermined change control plan (PCCP) that encompasses the following biocompatibility-related manufacturing changes, provided that they do not impact the properties of the device materials, for the devices under the above PMAs:1. Removal of a processing aid (solvent, lubricant, antifoaming agent, etc.), or cleaning agent2. Removal of a cleaning process3. Change in parameters (temperature, time, sonication, etc.) of a current cleaning process