- Device
- CapSure Epicardial Pacing Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P950024
- Supplement
- S105
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2022-11-22
- Decision code
- OK30
- Date received
- 2022-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Relocation of the Chemical Operations area within the same manufacturing facility (Medtronic Energy and Component Center) for selected components.