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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 NameENTRUST 30J & 35J ICD & VIRTUOSO DR & VR ICD
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Namedual chamber icds
ApplicantMEDTRONIC VASCULAR
PMA NumberP980016
Supplement NumberS104
Date Received07/12/2007
Decision Date08/10/2007
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Changes including: 1) moving the accelerometer testing operation earlier in the manufacturing flow; 2) moving the patient alert resting operation earlier in the manufacturing process; and 3) performing the medical adhesive curing and device pre-heat process in a single oven.
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