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: VITATRON LEGACY 11 DR
• Classification Name: implantable pacemaker pulse-generator
• Generic Name: pulse generator
• Regulation Number: 870.3610
• Applicant: MEDTRONIC VASCULAR
• PMA Number: P890003
• Supplement Number: S076
• Date Received: 08/27/2004
• Decision Date: 09/22/2004
• Product Code: DXY [ Registered Establishments with DXY ]
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day notice
• Supplement Reason: process change: sterilization
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change in the sterilization process.