PMA P920015
- Device
- MEDTRONIC(R) TRANSVENE LEAD SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S274
- Product code
- NVY
- Decision date
- 2026-08-19
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- the implementation of a new Controlled Environment Area at the Medtronic Bakken Research Center
Current openFDA PMA Record#
- Device
- MEDTRONIC(R) TRANSVENE LEAD SYSTEM
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S307
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2026-08-19
- Decision code
- OK30
- Date received
- 2026-07-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the implementation of a new Controlled Environment Area at the Medtronic Bakken Research Center