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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 NameBONNIE (TM) PTCA CATHERS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Namecatheter
Regulation Number870.5100
ApplicantSCHNEIDER INTL., LTD.
PMA NumberP880027
Supplement NumberS052
Date Received09/09/1997
Decision Date08/27/1998
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 a new ptca catheter. The device, as modified, will be marketed under the trade name bypass speedy(tm) monorail(r) ptca dilatation catheter and is indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpsoe of improving myocardial perfusion.
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