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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 NameCOHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
Generic Namelaser
ApplicantLUMENIS, INC.
PMA NumberP940011
Supplement NumberS003
Date Received07/10/1998
Decision Date11/24/1998
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to relocate manufacturing facility from coherent, inc. , 3270 w. Bayshore rd. , palo alto, ca to coherent, inc. , 2400 condensa st. , santa clara, ca.
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