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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 NameTITAN MEGA AND TITAN MEGA XL
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
ApplicantCORDIS CORP.
PMA NumberP880003
Supplement NumberS064
Date Received09/16/1996
Decision Date02/10/1997
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for titan mega and titan mega xl ptca dilatation catheters. These catheters are indicated for balloon dilatation of th estenotic portion of a coaronary artery or byapss graft stenosis for the purpose of improving myocardial perfusion.
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