PMA P030036S157
- Device
- SelectSecure Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S157
- Product code
- NVN
- Decision date
- 2026-03-06
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- expanding the existing lead repackaging process to include additional trigger defects
Current openFDA PMA Record#
- Device
- SelectSecure Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S157
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-03-06
- Decision code
- OK30
- Date received
- 2026-02-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- expanding the existing lead repackaging process to include additional trigger defects