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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 NamePARADYM RF CRT-D
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantSORIN GROUP USA INC.
PMA NumberP060027
Supplement NumberS038
Date Received03/13/2012
Decision Date05/09/2013
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the smartview home monitor. The device, as modified, will be marketed under the trade name smartview home monitor and is indicated for use with sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; it will not operate with other lines such as and not limited to digital, dsl or optical for the pstn device and the smartview monitor is designed for use with the sorin radio frequency implanted cardiac device only for gprs devices.
Approval Order Approval Order
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