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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 NameHYBRID PTCA CATHETER
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nametransluminal coronary angioplasty catheters, per
Regulation Number870.5100
ApplicantBAXTER HEALTHCARE CORP.
PMA NumberP850021
Supplement NumberS012
Date Received11/05/1990
Decision Date02/04/1991
Product Code
LOX[ Registered Establishments with LOX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
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