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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 Namecatheter
Regulation Number870.5100
PMA NumberP880027
Supplement NumberS050
Date Received06/09/1997
Decision Date10/24/1997
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 15 mm length models of the bonnie(tm) ptca catheter. The new models will be marketed under the trade name bonnie(tm) monorail(r) percutaneous transluminal coronary agnioplasty (ptca) catheters and are indicated for balloon dilatation of the stenotic portion of a coronary arteyr or bypass graft stenosis for the purpose of improving myocardial perfusion.