PMA P980016S743
- Device
- Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S743
- Product code
- LWS
- Decision date
- 2020-07-08
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Add additional tests to the final functional test program at a BTLE module supplier.
Current openFDA PMA Record#
- Device
- Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD
- Applicant
- Medtronic Cardiac Rhythm Disease Management
- PMA number
- P980016
- Supplement
- S743
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2020-07-08
- Decision code
- OK30
- Date received
- 2020-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add additional tests to the final functional test program at a BTLE module supplier.