PMA P920015S306
- Device
- Sprint Quattro Lead (6946M)
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S306
- Product code
- NVY
- Decision date
- 2026-06-24
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- reduced stability testing intervals for various cardiac lead families containing Dexamethasone or Beclomethasone Dipropionate
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead (6946M)
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S306
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2026-06-24
- Decision code
- OK30
- Date received
- 2026-05-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- reduced stability testing intervals for various cardiac lead families containing Dexamethasone or Beclomethasone Dipropionate