PMA P920015S300
- Device
- Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S300
- Product code
- NVY
- Decision date
- 2025-07-09
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- to automate a packaging tray loading process for lead accessories
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S300
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2025-07-09
- Decision code
- OK30
- Date received
- 2025-06-10
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to automate a packaging tray loading process for lead accessories