MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
FDA premarket approval P990018/S002 · decided 2002-07-12
Approval details
- PMA number
- P990018
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MENICON Z(TM) (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS FOR 30-DAY EXTENDED WEAR
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Menicon Co, Ltd.
- Date received
- 2001-11-28
- Decision date
- 2002-07-12
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nagoya
- Statement
- APPROVAL FOR THE MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS. THIS DEVICE IS INDICATED FOR: MENICON Z (TISILFOCON A) SPHERICAL, ASPHERIC, NON-PRISM BALLAST TORIC AND NON-PRISM BALLAST MULTIFOCAL LENSES ARE INDICATED FOR EXTENDED WEAR (FROM 1 TO 30 DAYS BETWEEN REMOVALS FOR CLEANING AND DISINFECTION OF THE LENSES, AS RECOMMENDED BY THE EYECARE PROFESSIONAL) FOR THE CORRECTION OF REFRACTIVE ERROR (MYOPIA, HYPEROPIA, PRESBYOPIA AND/OR ASTIGMATISM) IN NON-APHAKIC PERSONS WITH NON-DISEA
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510(k) clearances by this applicant
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|---|---|---|
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| MENICON UNIQUE PH MULTI-PURPOSE SOLUTION (K130805) | Menicon Co, Ltd. | 2013-07-03 |
| MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENS (K122273) | Menicon Co, Ltd. | 2013-01-02 |