|
Device | ANGIO DYNAMICS 630PDT LASER |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | Pinnacle Biologics, Inc. 2801 Lakeside Drive. Suite 210 Bannockburn, IL 60015 |
PMA Number | P990021 |
Supplement Number | S002 |
Date Received | 05/26/2009 |
Decision Date | 10/13/2010 |
Product Code |
MVF |
Advisory Committee |
General & Plastic Surgery |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE USE OF AN ALTERNATIVE SOURCE OF LASER DIODE AND MODIFICATION OF THE THERMAL MANAGEMENT OF THE DEVICE. |