PMA P900061S166
- Device
- Epicardial Patch Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- Product code
- LWS
- Decision date
- 2021-11-10
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Change to the degreaser and degreaser system used at the supplier Lake Region Medical.
Current openFDA PMA Record#
- Device
- Epicardial Patch Lead
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P900061
- Supplement
- S166
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2021-11-10
- Decision code
- OK30
- Date received
- 2021-11-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the degreaser and degreaser system used at the supplier Lake Region Medical.