- Device
- Sprint Quattro Lead, Y Adaptor/Extender
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S258
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2021-08-19
- Decision code
- OK30
- Date received
- 2021-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of incoming inspections of silicone rubber tubing received at Medtronic Rice Creek facility to replace inspections no longer occurring at MECC.