RIGID GAS PERMEABLE CONTACT LENS
FDA premarket approval P870024/S047 · decided 2009-12-11
Approval details
- PMA number
- P870024
- Supplement
- S047
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- RIGID GAS PERMEABLE CONTACT LENS
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2009-06-17
- Decision date
- 2009-12-11
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR PACKAGING THE CONTACT LENSES IN A DIFFERENT MULTIPURPOSE SOLUTION WHEN SHIPPED WET.
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