QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
FDA premarket approval P050026 · decided 2006-04-04
Approval details
- PMA number
- P050026
- Trade name
- QUANTEL ACTIVIS LASER AND ZSL30 ACT, ZSL120 ACT, AND HSBMBQ ACT SLIT LAMP ADAPTERS
- Generic name
- System, laser, photodynamic therapy
- Applicant
- Bausch + Lomb Ireland Limited
- Date received
- 2005-07-14
- Decision date
- 2006-04-04
- Days to decision
- 264 days
- Decision code
- APPR
- Product code
- MVF
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bridgewater, NJ
- 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.
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