Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: EN TRUST ICD, INTRINSIC ICD, MARQUIS DR ICD, MARQUIS VR ICD, MAXIMO DR ICD, MAXIMO DR ICD, MAXIMO II DF4 ICD, MAXIMO II
• Classification Name: implantable cardioverter defibrillator (non-crt)
• Applicant: MEDTRONIC INC.
• PMA Number: P980016
• Supplement Number: S370
• Date Received: 07/25/2012
• Decision Date: 08/17/2012
• Product Code: LWS [ Registered Establishments with LWS ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
New pressure test equipment used to verify hermeticity.