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: OVATIO VR 6250 & DR 6550 ICDS
• Classification Name: defibrillator, implantable, dual-chamber
• Generic Name: implantable cardioverter-defibrillator with active housing
• Applicant: ELA MEDICAL, INC.
• PMA Number: P980049
• Supplement Number: S029
• Date Received: 02/19/2008
• Decision Date: 12/05/2008
• Product Code: MRM [ Registered Establishments with MRM ]
• Advisory Committee: Cardiovascular
• Supplement Type: 135 review track for 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a change in the lot acceptance life test.