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: PARADYM CRT-D MODEL 8750
• Classification Name: defibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
• Applicant: ELA MEDICAL, INC.
• PMA Number: P060027
• Supplement Number: S015
• Date Received: 09/29/2009
• Decision Date: 04/07/2010
• Product Code: NIK [ Registered Establishments with NIK ]
• Advisory Committee: Cardiovascular
• Supplement Type: normal 180 day track
• Supplement Reason: change design/components/specifications - other
• Expedited Review Granted?: No
• Combination Product: No

Review Memo

Review Memo

Approval Order Statement 
Approval for the paradym vr model 8250 and dr model 8550 with smartview 2. 18ug1 programmer software and the paradym crt-d model 8750 with hardware and manufacturing changes and labeling and programmer software changes to the ovatio vr model 6250, dr model 6550 and crt-d model 6750. The device, as modified, will be marketed under the trade name paradym vr model 8250 and paradym dr model 8550 with smartview 2. 18ug1 and is indicated for use in patients who are at high risk of sudden cardiac death due to ventricular tachyarrhythmias and who have experienced one of the following situations: survival of at least one episode of cardiac arrest manifested by the loss of consciousness) due to ventricular tachyarrhythmia, recurrent poorly tolerated sustained ventricular tachycardia.

Approval Order

Approval Order