PMA P080006S190

Device: Medtronic Attain Ability Model 4196 Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S190
Product code: OJX
Decision date: 2025-03-20
Classification: Cardiovascular
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
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: Medtronic Attain Ability Model 4196 Lead
Applicant: Medtronic, Inc.
PMA number: P080006
Supplement: S190
Product code: OJX
Generic name: Drug eluting permanent left ventricular (lv) pacemaker electrode
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