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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 NameMEDI-TECH CORONARY BALLOON DILATATION CATHETER SYS
Classification Namecatheters, transluminal coronary angioplasty, percutaneous
Generic Nameptca system
Regulation Number870.5100
ApplicantMANSFIELD SCIENTIFIC, INC.
PMA NumberP840040
Supplement NumberS010
Date Received02/23/1989
Decision Date05/01/1989
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
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