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 | BLU-U |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | Sun Pharmaceutical Industries, Inc. 29 Dunham Road Billerica, MA 01821 |
PMA Number | P990019 |
Supplement Number | S002 |
Date Received | 09/30/2002 |
Decision Date | 01/09/2003 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR EXTENSION OF THE CALIBRATION INTERVAL FROM THE CURRENTLY APPROVED 500 CYCLES (WITH A 50 CYCLE BUFFER) TO 1600 CYCLES (WITH A 50 CYCLE BUFFER). |
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