PMA P920015S285
- Device
- Y Adaptor/Extender Kit, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S285
- Product code
- NVY
- Decision date
- 2024-04-16
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- an update to the cleaning process and solution at a critical supplier of lead components
Current openFDA PMA Record#
- Device
- Y Adaptor/Extender Kit, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S285
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2024-04-16
- Decision code
- APPR
- Date received
- 2024-01-02
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the cleaning process and solution at a critical supplier of lead components