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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 NameNC STORMER OTW BALLOON DILATATION CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca catheter
Regulation Number870.5100
ApplicantMEDTRONIC IRELAND
PMA NumberP790017
Supplement NumberS084
Date Received09/23/2005
Decision Date10/17/2005
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change which would increase the length of the distal outer shaft of nc stormer otw balloon dilatation catheter from 21. 5 cm - 23. 5 cm to 23. 0 cm - 24. 0 cm.
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