- Device
- Model 5071 Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P120017
- Supplement
- S038
- Product code
- DTB
- Generic name
- permanent 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