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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCOHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS
ApplicantLumenis, Inc.
3959 W. 1820 S.
Salt Lake City, UT 84104
PMA NumberP940011
Supplement NumberS003
Date Received07/10/1998
Decision Date11/24/1998
Withdrawal Date01/14/2014
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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