PMA P870024

Device: FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
Applicant: CooperVision, Inc.
PMA number: P870024
Supplement: S062
Product code: MWL
Decision date: 2022-06-16
Generic name: Lens, contact (rigid gas permeable), extended wear
Approval order 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.

Current openFDA PMA Record#

Device: FluoroPerm30 (paflufocon C), FluoroPerm60 (paflufocon B), FluoroPerm92 (paflufocon A), Paragon HDS (paflufocon B) Rigid
Applicant: CooperVision, Inc.
PMA number: P870024
Supplement: S060
Product code: MWL
Generic name: Lens, contact (rigid gas permeable), extended wear
Decision date: 2022-06-16
Decision code: APPR
Date received: 2022-03-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.