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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.
 
DeviceACS OTW PHOTON CORONARY DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
ApplicantAdvanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula, CA 92591
PMA NumberP810046
Supplement NumberS199
Date Received10/08/1999
Decision Date10/29/1999
Reclassified Date10/08/2010
Product Codes DYG LOX 
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: 1) modification of the manufacturing process by which the proximal adapter is bonded to the proximal portion of the ACS OTW PHOTON(TM) Coronary Dilatation Catheter; and 2) modification of the adaptation tensile test at the finished device audit process.
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