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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 NameECLIPSE TMR HOLMIUM LASER SYSTEM
Classification Namesystem, laser, transmyocardial revascularization
Generic Namesystem, laser, transmyocardial revascularization
ApplicantCRYOLIFE, INC.
PMA NumberP970029
Supplement NumberS008
Date Received10/05/2001
Decision Date11/29/2001
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in manufacturing location to ventrex, inc. Ventura, california.
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