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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.
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca dilation catheters
Regulation Number870.5100
PMA NumberP880003
Supplement NumberS071
Date Received07/17/1997
Decision Date08/04/1998
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new indication for use: the post-delivery expansion of the palmaz-schatz(tm) coronary stet, with the titan(tm) and tita(tm) xl ptca dilatation catheters (3. 0 mm, 3. 25 mm, 3. 5mm, 3. 75 mm balloon diamters with 9 mm and 18 mm balloon lengths, and a 4. 0 mm balloon diameter with 9 mm balloon length. ).