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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 RHEOLYTIC THROMBECTOMY SYSTEN
Classification Namecatheter, coronary, atherectomy
Generic Namecatheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS024
Date Received12/20/2007
Decision Date06/17/2008
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternative hydrophilic coating material and supplier (dsm biomedical, gleen, netherlands) used on the distal shaft of the spiroflex family of catheters (spiroflex and sprioflex vg) and approval to perform the manufacturing coating process of the new dsm hydrophilic coating at the possis facility, minneapolis, minnesota.
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