MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
FDA premarket approval P990018/S001 · decided 2000-09-06
Approval details
- PMA number
- P990018
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- Menicon Co, Ltd.
- Date received
- 2000-07-28
- Decision date
- 2000-09-06
- Days to decision
- 40 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Nagoya
- Statement
- APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.
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510(k) clearances by this applicant
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|---|---|---|
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| Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens (K180004) | Menicon Co, Ltd. | 2018-02-22 |
| Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses (K173136) | Menicon Co, Ltd. | 2017-11-16 |
| Menicon Saline Rinse Solution (K151768) | Menicon Co, Ltd. | 2015-08-28 |
| 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 |