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 MODEL 5076 LEAD
• Classification Name: permanent pacemaker electrode
• Generic Name: pacing lead
• Regulation Number: 870.3680
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P930039
• Supplement Number: S018
• Date Received: 02/10/2004
• Decision Date: 03/10/2004
• 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: Yes

Approval Order Statement 
Use of med-2000 silicone adhesive as an alternative for med-1137 silicone adhesive.