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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 NameANGIOJET RHEOLOYTIC THROMBECTOMY SYSTEM
Classification Namecatheter, coronary, atherectomy
ApplicantMEDRAD, INC.
PMA NumberP980037
Supplement NumberS040
Date Received08/17/2012
Decision Date10/16/2012
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the packaging tray material for the angiojet ultra xmi, ultra spiroflex, and ultra spiroflex vg thrombectomy sets from petg to petg denest, as well as changing the manufacturing of these packaging trays from perfecseal to brookdale.
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