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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameOVATIO VR 6250 AND OVATIO DR 6550
Classification Namedefibrillator, implantable, dual-chamber
Generic Nameimplantable cardioverter-defibrillator with active housing
PMA NumberP980049
Supplement NumberS040
Date Received08/13/2008
Decision Date10/31/2008
Product Code
MRM[ Registered Establishments with MRM ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a modification to the automatic sensitivity control (asc) algorithm in the ovatio vr 6250, ovatio dr 6550 and ovatio crt 6750.