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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.
 
DeviceD114S/NEPTUNE X-ACT OVER-THE-WIRE BALLOON DILATATION CATHETER
Generic NameCatheters, transluminal coronary angioplasty, percutaneous
Regulation Number870.5100
ApplicantMedtronic, Ireland
Parkmore Business Park W.
Galway 
PMA NumberP790017
Supplement NumberS072
Date Received07/14/2000
Decision Date07/24/2000
Reclassified Date10/08/2010
Product Code LOX 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN SUPPLIER OF THE HIGH MOLECULAR WEIGHT HIGH-DENSITY POLYETHYLENE INNER SHAFT USED IN AVE IRELAND'S MANUFACTURING NEPTUNE(TM) X-ACT(R) AND D114S OVER-THE-WIRE PTCA CATHETERS OPERATIONS.
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