PMA P900061S162
- Device
- ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P900061
- Supplement
- S162
- Product code
- LWS
- Decision date
- 2020-12-15
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Update the manufacturing execution system to FACTORYworks Release 9.8.
Current openFDA PMA Record#
- Device
- ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P900061
- Supplement
- S162
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-12-15
- Decision code
- OK30
- Date received
- 2020-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Update the manufacturing execution system to FACTORYworks Release 9.8.