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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.
 
DeviceAngioSculpt RX PTCA Scoring Balloon Catheter, AngioSculpt Evo RX PTCA Scoring Balloon Catheter with Hydrophilic Coating
Generic NameCatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
ApplicantSpectranetics Corp.
5055 Brandin Ct.
Fremont, CA 94538
PMA NumberP050018
Supplement NumberS032
Date Received06/26/2023
Decision Date07/07/2023
Product Code NWX 
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  
Alternate supplier for a catheter component.
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