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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.
 
DeviceMODEL 8005 CIRCUCOOL PUMP
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
150 Baytech Dr.
San Jose, CA 95134
PMA NumberP980003
Supplement NumberS026
Date Received10/29/2010
Decision Date11/19/2010
Withdrawal Date02/28/2024
Product Code LPB 
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  
RETROSPECTIVE OUTSOURCING OF COMPONENTS BY A SUPPLIER.
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