FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
FDA premarket approval P870024/S060 · decided 2022-06-16
Approval details
- PMA number
- P870024
- Supplement
- S060
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
- Generic name
- Lens, contact (rigid gas permeable), extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2022-03-21
- Decision date
- 2022-06-16
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- MWL
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- Approval for a new manufacturing site, Paragon Vision Sciences. Inc. located at 2120 W. Guadalupe Rd. Gilbert, Arizona 85233. This facility is responsible for manufacturing of the contact lens materials and finished lenses, shipping, R&D, and administration.
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