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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 NameAORTIC VALVULOPLASTY BALLOON DILATATION CATHETER
Classification Namepulse-generator, program module
Generic Namepercutaneous transluminal balloon
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP880065
Supplement NumberS005
Date Received02/27/2001
Decision Date03/27/2001
Product Code
LOT
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change from an internal particulate maximum level to an internal particulate action level of 75,000 particles >=10 microns for the finished product.
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