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.
Approval to relocate manufacturing facility from coherent, inc. , 3270 w. Bayshore rd. , palo alto, ca to coherent, inc. , 2400 condensa st. , santa clara, ca.
| Device | COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS |
| Applicant | LUMENIS, INC. |
| Date Received | 1998-07-10 |
| Decision Date | 1998-11-24 |
| PMA | P940011 |
| Supplement | S003 |
| Advisory Committee | General & Plastic Surgery |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LUMENIS, INC. 3959 West 1820 South salt Lake City, UT 84104 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940011 | Original Filing | |
| S003 | 1998-07-10 | Normal 180 Day Track |
| S002 | 1998-03-25 | Normal 180 Day Track |
| S001 | 1997-02-14 | Normal 180 Day Track |