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: CAPSURE SENSE BIPOLAR LEAD
• Generic Name: Permanent defibrillator electrodes
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P830061
• Supplement Number: S064
• Date Received: 05/05/2011
• Decision Date: 10/04/2012
• Product Code: NVY
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT MEDTRONIC SINGAPORE PTE. LTD, IN SINGAPORE.