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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePOSSIS ANGIOJET(R) RHEOLYTIC(TM) THROMBECTOMY SYSTEM - CORONARY USE
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantBoston Scientific Corp
One Scimed Pl.
Maple Grove, MN 55311
PMA NumberP980037
Supplement NumberS002
Date Received02/29/2000
Decision Date03/17/2000
Product Code MCX 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the additiion of a label to the current inventory of the LF 140 Catheter which reads "Caution: Do not inject fluids in catheter outflow lumen".
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