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: CAPSURE SP NOVUS Z NOVUS
• Classification Name: permanent pacemaker electrode
• Generic Name: electrode, pacemaker, permanent
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P850089
• Supplement Number: S053
• Date Received: 03/01/2004
• Decision Date: 06/08/2004
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval to market these lead models manufactured using med 2000 silicone adhesive.