|
Device | COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM |
Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
Applicant | LUMENIS 3959 WEST 1820 SOUTH SALT LAKE CITY, UT 84104 |
PMA Number | P990049 |
Date Received | 08/20/1999 |
Decision Date | 04/12/2000 |
Withdrawal Date
|
09/10/2010 |
Product Code |
MVF |
Docket Number | 00M-1299 |
Notice Date | 04/12/2000 |
Advisory Committee |
General & Plastic Surgery |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for the treatment of age-related macular degeneration in patients with predominantly classic subfoveal choroidal neovascularization. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Supplements: |
S001 |