PMA P030036S161
- Device
- SelectSecure Lead 3830
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S161
- Product code
- NVN
- Decision date
- 2026-08-05
- Classification
- Cardiovascular
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Approval order statement
- the implementation of additional laser welding equipment
Current openFDA PMA Record#
- Device
- SelectSecure Lead 3830
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P030036
- Supplement
- S161
- Product code
- NVN
- Generic name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
- Decision date
- 2026-08-05
- Decision code
- OK30
- Date received
- 2026-07-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of additional laser welding equipment