PMA P900061S139
- Device
- EPICARDIAL PATCH LEAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P900061
- Supplement
- S139
- Product code
- LWS
- Decision date
- 2016-01-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- EPICARDIAL PATCH LEAD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P900061
- Supplement
- S139
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2016-01-21
- Decision code
- OK30
- Date received
- 2015-12-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REQUESTED UPDATES TO THE STAINLESS STEEL COMPONENT PASSIVATION PROCESSES FOR THE DEVICES.