PMA P240036S003
- Device
- OmniaSecure™ MRI SureScan™ Lead Model 3930M
- Applicant
- Medtronic, Inc.
- PMA number
- P240036
- Supplement
- S003
- Product code
- NVY
- Decision date
- 2025-10-30
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- allow a manufacturing supplier site change for the wire coil component of the Omnia Secure lead.
Current openFDA PMA Record#
- Device
- OmniaSecure™ MRI SureScan™ Lead Model 3930M
- Applicant
- Medtronic, Inc.
- PMA number
- P240036
- Supplement
- S003
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2025-10-30
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- allow a manufacturing supplier site change for the wire coil component of the Omnia Secure lead.