PMA P850051

Device: Activitrax Models 8400, 8402, 8403
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S082
Product code: LWO
Decision date: 2025-03-20
Generic name: Pulse-generator, single chamber, sensor driven, implantable
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: Activitrax Models 8400, 8402, 8403
Applicant: Medtronic, Inc.
PMA number: P850051
Supplement: S085
Product code: LWO
Generic name: Pulse-generator, single chamber, sensor driven, implantable
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