PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
FDA premarket approval P050031 · decided 2006-11-16
Approval details
- PMA number
- P050031
- Trade name
- PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2005-08-26
- Decision date
- 2006-11-16
- Days to decision
- 447 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR THE PARAGON Z CRT (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENSES FOR CONTACT LENS CORNEAL REFRACTIVE THERAPY. THE LENSES ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN THE CONTACT LENS CORNEAL REFRACTIVE THERAPY FITTING PROGRAM FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 6.00 DIOPTERS IN EYES WITH ASTIGMATISM UP TO 1.75 DIOPTERS. THE LENSES MAY BE DISINFECTED USING ONLY A CHEMICAL DISINFECTION
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