PMA P980016S360

Device: MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S360
Product code: LWS
Decision date: 2013-03-18
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: APPROVAL FOR A CHANGE TO THE INTERFACE USED WITH THE FINAL FUNCTIONAL TESTING EQUIPMENT.

Current openFDA PMA Record#

Device: MAXIMO II ICD, PROTECTA ICD, PROTECTA XT ICD, SECURA ICD, VIRTUOSO ICD, VIRTUOSO II DR/VR ICD
Applicant: Medtronic Cardiac Rhythm Disease Management
PMA number: P980016
Supplement: S360
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2013-03-18
Decision code: APPR
Date received: 2012-06-11
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE TO THE INTERFACE USED WITH THE FINAL FUNCTIONAL TESTING EQUIPMENT.