Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints
FDA premarket approval P870024/S058 · decided 2021-04-23
Approval details
- PMA number
- P870024
- Supplement
- S058
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Paragon HDS100 and Fluoroperm 151 Rigid Gas Permeable Contact Lenses in clear and tints
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2021-01-21
- Decision date
- 2021-04-23
- Days to decision
- 92 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a new manufacturing facility located at Paragon Vision Sciences, Inc., 2120 W Guadalupe Rd. Gilbert, Arizona.
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