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: PROTECTA DR/VR/XT DR/XT VR
• Classification Name: implantable cardioverter defibrillator (non-crt)
• Applicant: MEDTRONIC INC.
• PMA Number: P980016
• Supplement Number: S290
• Date Received: 04/05/2011
• Decision Date: 05/05/2011
• Product Code: LWS [ Registered Establishments with LWS ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Moving sterilization equipment within a facility and implementation of a bar code reader system.