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 | OPTIGUIDE (TM) CYLINDRICAL FIBER OPTIC |
Generic Name | SYSTEM, LASER, FIBER OPTIC, PHOTODYNAMIC THERAPY |
Applicant | Pinnacle Biologics, Inc. 2801 Lakeside Drive. Suite 210 Bannockburn, IL 60015 |
PMA Number | P940010 |
Supplement Number | S008 |
Date Received | 09/21/1999 |
Decision Date | 07/07/2000 |
Product Code |
MVG |
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 THE ADDITION OF SURGICAL TECHNOLOGIES, INC. AS AN ALTERNATE PACKAGING AND STERILIZATION SITE, AND MODIFICATIONS TO THE FIBER OPTIC REEL AND PRIMARY PACKAGING BOX. |
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