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: MEDTRONIC (R) CAPSURE (R) EPI PACING LEAD MODEL 4695
• Classification Name: permanent pacemaker electrode
• Generic Name: capsure epi epicardial steroid eluting pacing lead
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P950024
• Supplement Number: S004
• Date Received: 07/17/2001
• Decision Date: 08/08/2001
• 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 
Change in the supplier of polyetherurethane.