- Device
- OmniaSecure MRI SureScan Lead Model 3930M
- Applicant
- Medtronic, Inc.
- PMA number
- P240036
- Supplement
- S006
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2026-04-24
- Decision code
- APPR
- Date received
- 2026-03-25
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P240036/S004.