|
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 | S001 |
Date Received | 07/03/1996 |
Decision Date | 08/07/1996 |
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 CHANGE IN LABELING CONSISTING OF ADDING AN ADDITIONAL WARNING STATEMENT CONCERNING POSSIBLE LEAKAGE OF BLOOD INTO DIFFUSER CAP |