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 CRT & SITUS OTW LV
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Applicant: ELA MEDICAL, INC.
• PMA Number: P060027
• Supplement Number: S027
• Date Received: 07/16/2010
• Decision Date: 09/14/2010
• Product Code: NIK [ Registered Establishments with NIK ]
• 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 protocol.