PMA P850057
- Device
- CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)
- Applicant
- Ciba Vision Corporation
- PMA number
- P850057
- Supplement
- S006
- Product code
- LPM
- Decision date
- 2000-09-18
- Classification
- Lenses, Soft Contact, Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.
Current openFDA PMA Record#
- Device
- CUSTOM TINTED HYDROCURVE II HYDROCURVE II APHAKIC, SOFTMATE II AND HC3 TORIC (BUFILCON A)
- Applicant
- Ciba Vision Corporation
- PMA number
- P850057
- Supplement
- S006
- Product code
- LPM
- Generic name
- Lenses, soft contact, extended wear
- Decision date
- 2000-09-18
- Decision code
- APPR
- Date received
- 1999-12-23
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Approval order statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.