|
Device | OPTIGUIDE 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 | S007 |
Date Received | 07/08/1999 |
Decision Date | 08/13/1999 |
Product Code |
MVG |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for revision ot the package labeling and package insert labeling. The approved modifications include clarification of directions for use and device descriptions and simplification of use of trademark or registered trademark symbols. |