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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 NumberS041
Date Received05/16/2012
Decision Date05/30/2012
Product Code
NIK[ Registered Establishments with NIK ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The following changes: 1) an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier; 2) an update to the rework process; 3) in-sourcing of an electronic assembly; 4) clean room layout modification at saluggia, italy, plant, and; 5)an alternate method for a hybrid module wire bonding process.
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