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: EPICARDIAL LEADS AND ACCESSORIES
• Generic Name: Implantable cardioverter defibrillator (non-CRT)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P900061
• Supplement Number: S103
• Date Received: 05/13/2011
• Decision Date: 06/10/2011
• Product Code: LWS
• Advisory Committee: Cardiovascular
• Supplement Type: 30-Day Notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
CHANGE THE CLEANING AREA OF THE DEVICES.