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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 NameMANSFIELD SCI. AORTIC VALVULOPLASTY CATHETER
Classification Namepulse-generator, program module
Generic Namepercutaneous transluminal balloon
ApplicantSCIMED LIFE SYSTEMS, INC.
PMA NumberP880065
Supplement NumberS003
Date Received03/05/1997
Decision Date09/08/1997
Product Code
LOT
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for: 1) an alternate manufacturing and sterilization facility; 2) use of the oxyfume 2000 sterilant gas mixture for sterilization; 3) use of a parametric release instead of the biological indicators product release process; and 4) use of a revised labeling format, which replaces the mansfield name with the scimed(r) name.
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