ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
FDA premarket approval P030028 · decided 2004-09-10
Approval details
- PMA number
- P030028
- Trade name
- ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS (PIOL) VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS (PIOL)
- Generic name
- Lens, intraocular, phakic
- Applicant
- Ophtec BV
- Date received
- 2003-07-01
- Decision date
- 2004-09-10
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- MTA
- Advisory committee
- Ophthalmic
- Expedited review
- Yes
- Location
- Groningen
- Statement
- APPROVAL FOR THE ARTISAN (MODEL 206 AND 204) PHAKIC INTRAOCULAR LENS, ALSO KNOWN AS THE VERISYSE (VRSM5US AND VRSM6US) PHAKIC INTRAOCULAR LENS TO BE DISTRIBUTED BY ADVANCE MEDICAL OPTICS. THE DEVICE IS INDICATED FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA IN ADULTS WITH MYOPIA RANGING FROM -5 TO -20 DIOPTERS WITH LESS THAN OR EQUAL TO 2.5 DIOPTERS OF ASTIGMATISM AT THE SPECTACLE PLANE AND WHOSE EYES HAVE AN ANTERIOR CHAMBER DEPTH GREATER THAN OR EQUAL TO 3.2 MILLIMETERS; AND, 2) PATIENTS WITH
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