|
Device | OPTIGUIDE(TM) FIBER OPTIC DIFFUSER |
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 | S003 |
Date Received | 02/18/1997 |
Decision Date | 04/04/1997 |
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 LABELING CHANGES ASSOCIATED WITH THE INTRODUCTION OF A SECOND DISTRIBUTOR |