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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 Nameholmium laser system fiber optic delivery system handpiece
ApplicantCARDIOGENES
PMA NumberP970029
Supplement NumberS005
Date Received11/09/2000
Decision Date12/08/2000
Product Code
MNO[ Registered Establishments with MNO ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for two specific additional quality control inspection steps during the manufacturing of the sologrip handpiece and the addition of specific language in three places to the instructions for use for the sologrip handpiece.
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