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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 NameSIMPSON-ROBERT FAMILY OF CORONARY DILATATION CATHETERS
Classification Namestent, coronary
Generic Namepercutaneous transluminal coronary angioplasty balloon dilatation catheter
ApplicantABBOTT VASCULAR INC.
PMA NumberP810046
Supplement NumberS227
Date Received11/10/2008
Decision Date12/10/2008
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modification of the environmental monitoring action limits for viable air and surface testing in the manufacturing production areas.
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