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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 NameCUTTING BALLOON
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP950020
Supplement NumberS023
Date Received12/07/2006
Decision Date05/10/2007
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to implement an alternate location for preparation of a hydrophilic coating solution component known as pre-bioslide and approval for an alternat supplier of the polymer initiator aibn.
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