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/SENSE/SP NOVUS
• Classification Name: permanent pacemaker electrode
• Generic Name: electrode, pacemaker, permanent
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P830061
• Supplement Number: S036
• Date Received: 03/04/2003
• Decision Date: 04/03/2003
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: manufacturing
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Addition of an alternate supplier of polyetherurethane.