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) POLYURETHANE STEROID-ELUTING LEAD
• Classification Name: permanent pacemaker electrode
• Generic Name: electrode, pacemaker, permanent
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P830061
• Supplement Number: S026
• Date Received: 05/02/1996
• Decision Date: 08/12/1996
• Product Code: DTB [ Registered Establishments with DTB ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: process change: packaging
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Alternate packaging design.