PMA P920015S303
- Device
- Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M)
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S303
- Product code
- NVY
- Decision date
- 2026-02-13
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- to reduce the quantity of combination product reserve samples retained
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M)
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S303
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2026-02-13
- Decision code
- OK30
- Date received
- 2026-01-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to reduce the quantity of combination product reserve samples retained