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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameNEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC VASCULAR
PMA NumberP790017
Supplement NumberS073
Date Received08/28/2000
Decision Date12/21/2001
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change the supplier of the polyethylene terephthlate (pet) alloy balloon tubing used in the manufacturing of the devices.
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