PMA P920015S290
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S290
- Product code
- NVY
- Decision date
- 2024-07-05
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- to modify the distal tip lead body assembly process to help maintain the lead without curvature
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S290
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2024-07-05
- Decision code
- OK30
- Date received
- 2024-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the distal tip lead body assembly process to help maintain the lead without curvature