PMA P920015S292
- Device
- IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S292
- Product code
- NVY
- Decision date
- 2024-10-01
- Classification
- Cardiovascular
- Generic name
- Permanent defibrillator electrodes
- Approval order statement
- removal of the vapor degrease cleaning process and addition of a duplicate ultrasonic cleaning process for select parts
Current openFDA PMA Record#
- Device
- IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead
- Applicant
- Medtronic, Inc.
- PMA number
- P920015
- Supplement
- S292
- Product code
- NVY
- Generic name
- Permanent defibrillator electrodes
- Decision date
- 2024-10-01
- Decision code
- OK30
- Date received
- 2024-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- removal of the vapor degrease cleaning process and addition of a duplicate ultrasonic cleaning process for select parts