PMA P240036S005
- Device
- OmniaSecure™ MRI SureScan™ Lead Model 3930M
- Applicant
- Medtronic, Inc.
- PMA number
- P240036
- Supplement
- S005
- Product code
- NVY
- Decision date
- 2026-04-24
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- removing a redundant inspection and manufacturing tolerance changes for lead over-molded connector assemblies
Current openFDA PMA Record#
- Device
- OmniaSecure™ MRI SureScan™ Lead Model 3930M
- Applicant
- Medtronic, Inc.
- PMA number
- P240036
- Supplement
- S005
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2026-04-24
- Decision code
- OK30
- Date received
- 2026-03-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removing a redundant inspection and manufacturing tolerance changes for lead over-molded connector assemblies