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 DR MODEL 6550 AND OVATIO VR MODEL 6260
• Classification Name: defibrillator, implantable, dual-chamber
• Generic Name: implantable cardioverter-defibrillator with active housing
• Applicant: ELA MEDICAL, INC.
• PMA Number: P980049
• Supplement Number: S027
• Date Received: 05/25/2007
• Decision Date: 10/23/2007
• Product Code: MRM [ Registered Establishments with MRM ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.