PMA P920015S297

Device: Medtronic(R) Transvene Lead System
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S297
Product code: NVY
Decision date: 2025-03-20
Classification: Cardiovascular
Generic name: Permanent defibrillator electrodes
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(R) Transvene Lead System
Applicant: Medtronic, Inc.
PMA number: P920015
Supplement: S297
Product code: NVY
Generic name: Permanent defibrillator electrodes
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