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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 ULTRA THOMRBECTOMY SET, ANGIOJET ULTRA SPIROFLEX THOMBRBECTOMY SET, VG THOMRBECTOMY SET, DISTAFLEX THOMBRBECTOM
Classification Namecatheter, coronary, atherectomy
ApplicantBAYER MEDICAL CARE INC.
PMA NumberP980037
Supplement NumberS042
Date Received06/05/2014
Decision Date09/02/2014
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the design and manufacturing process of the mid-joint connection on the angiojet ultra thrombectomy sets.
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