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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 PTCA SCORING BALLOON CATHETER
Classification Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Generic Namecatheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring
Applicant
SPECTRANETICS CORP.
5055 brandin court
fremont, CA 94538
PMA NumberP050018
Supplement NumberS017
Date Received05/10/2012
Decision Date01/10/2013
Product Code
NWX[ Registered Establishments with NWX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A NEW BALLOON LENGTH, AND TO INCORPORATE DESIGN, MANUFACTURING PROCESS AND LABELING CHANGES FOR THE RAPID EXCHANGE (RX) DELIVERY SYSTEM.
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