|
Device | OPTIGUIDE CYLINDRICAL FIBER OPTIC(DCYL2 DIFFUSER SERIES) |
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 | S006 |
Date Received | 02/08/1999 |
Decision Date | 03/04/1999 |
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 the additional indication for use for the reduction of obstruction and palliation of symptoms in patients with completely or partially obstructing endobronchial nonsmall cell lung cancer (NSCLC). |