| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS |
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| Generic Name | SYSTEM, LASER, PHOTODYNAMIC THERAPY |
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| Applicant | Bausch + Lomb Ireland Limited
400 Somerset Corporate Blvd
Bridgewater, NJ 08807 |
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| PMA Number | P050026 |
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| Date Received | 07/14/2005 |
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| Decision Date | 04/04/2006 |
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| Product Code |
MVF |
| Docket Number | 06M-0162 |
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| Notice Date | 04/18/2006 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | Yes |
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Approval Order Statement
APPROVAL FOR THE QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS. THE DEVICE IS INDICATED FOR THE PHOTOACTIVATION OF THE LIGHT ACTIVATED DRUG VISUDYNE (VERTEPORFIN FOR INJECTION) IN PHOTODYNAMIC THERAPY FOR THE TREATMENT OF PATIENTS WITH PREDOMINANTLY CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO AGE-RELATED MACULAR DEGENERATION, PATHOLOGIC MYOPIA, OR PRESUMED OCULAR HYSTOPLASMOSIS. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
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| Supplements: |
S001 S002 |
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