- Device
- HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M)
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S299
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2025-05-30
- Decision code
- OK30
- Date received
- 2025-05-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- new manufacturing equipment used in Cable Prep and Crimp steps of ring cable component manufacturing