PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..
FDA premarket approval P870024/S043 · decided 2002-06-13
Approval details
- PMA number
- P870024
- Supplement
- S043
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- PARAGON CRT (PAFLUFOCON B), PARAGON CRT 100 (PAFLUFOCON D), PARAGON QUADRA RG (PAFLUFOCON B) AND PARAGON QUADRA RG 100..
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- CooperVision, Inc.
- Date received
- 2001-10-02
- Decision date
- 2002-06-13
- Days to decision
- 254 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR THE FOLLOWING DEVICES AND INDICATIONS: THE PARAGON CRT (PAFLUFOCON B) AND PARAGON CRT 100 (PAGLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES FOR CORNEAL REFRACTIVE THERAPY ARE INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR IN A CONTACT LENSES 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
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