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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.
 
DeviceSIMPSON CORONARY ATHEROCATH-GTO
Generic NameCATHETER, CORONARY, ATHERECTOMY
ApplicantAbbott Vascular
26531 Ynez Rd., Bldg. G, Mailing P.O. 9018
Temecula, CA 92590
PMA NumberP890043
Supplement NumberS034
Date Received09/13/1999
Decision Date10/12/1999
Withdrawal Date09/05/2014
Product Code MCX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The 30-Day Notice requested implementation of two additional on-line inspections to the current manufacturing process to provide added assurance that the manufacturing step for attaching the nose cone to the housing has been performed correctly.
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