PMA P980016S746

Device: Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S746
Product code: LWS
Decision date: 2020-07-21
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Update specifications and methodologies of the Titan final functional tests for select ICD and CRT-D devices.

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: S746
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2020-07-21
Decision code: OK30
Date received: 2020-06-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update specifications and methodologies of the Titan final functional tests for select ICD and CRT-D devices.