PMA P920015S272
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S272
- Product code
- NVY
- Decision date
- 2022-10-25
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- Add two ethylene oxide sterilization systems at Medtronics Singapore Operations.
Current openFDA PMA Record#
- Device
- Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S272
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2022-10-25
- Decision code
- OK30
- Date received
- 2022-10-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add two ethylene oxide sterilization systems at Medtronics Singapore Operations.