Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR
• Generic Name: DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER
• Applicant: MicroPort CRM USA Inc.; 5640 Airline Road; Arlington, TN 38002
• PMA Number: P980049
• Supplement Number: S131
• Date Received: 04/19/2018
• Decision Date: 05/14/2018
• Product Code: MRM
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Addition of an alternate automated visual inspection for incoming inspection of die after dicing.