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. |
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Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
Applicant | LUMENIS, INC. 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 |
PMA Number | P940011 |
Supplement Number | S003 |
Date Received | 07/10/1998 |
Decision Date | 11/24/1998 |
Withdrawal Date
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01/14/2014 |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
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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