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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.
 
DevicePERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA)
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantBOSTON SCIENTIFIC
One Scimed Place
Maple Grove, MN 55311
PMA NumberP880027
Supplement NumberS062
Date Received05/29/2002
Decision Date06/25/2002
Withdrawal Date 04/13/2007
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
ALTERNATIVE BACTERIAL ENDOTOXIN TESTING METHOD, THE KINETIC-TURBIDIMETRIC METHOD, TO TEST WATER SAMPLES AND PRODUCT EXTRACTS.
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