VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)
FDA premarket approval P870024/S042 · decided 2000-01-31
Approval details
- PMA number
- P870024
- Supplement
- S042
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- VISIONS MADE WITH PARAGON HDS (PAFLUFOCON B)
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 1999-07-12
- Decision date
- 2000-01-31
- Days to decision
- 203 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval is for wet shipping and up to 30 day storage of the extended wear rigid gas permeable lenses in Alcon Wetting, Soakig, Conditioning and Disinfecting Solution ID 84392.
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