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 Z NOVUS/CAPSURE SP NOVUS TRANSVENOUS TINED PACING LEADS
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P850089
• Supplement Number: S039
• Date Received: 04/20/1998
• Decision Date: 08/12/1998
• Product Code: DTB
• Advisory Committee: Cardiovascular
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement  
Approval for a manufacturing site lcoated at Medtronic Puerto Rico, Inc. (MPRI), Road 149, Rm. 56.3, Villalba, Puerto Rico 00755.