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 | PHOTOFRIN 630 PDT Laser |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | Pinnacle Biologics, Inc. 2801 Lakeside Drive. Suite 210 Bannockburn, IL 60015 |
PMA Number | P990021 |
Supplement Number | S004 |
Date Received | 08/02/2017 |
Decision Date | 01/17/2018 |
Product Code |
MVF |
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 | Yes |
Approval Order Statement Approval for the PHOTOFRIN 630 PDT Laser to be manufactured by UnionMed Tech, Inc. Bridgewater, New Jersey. |
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