PMA N17752S037

Device
SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)
Applicant
Ciba Vision Corporation
PMA number
N17752
Supplement
S037
Product code
LPL
Decision date
2000-09-18
Classification
Lenses, Soft Contact, Daily Wear
Generic name
Lenses, soft contact, daily wear
Approval order statement
APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.

Current openFDA PMA Record#

Device
SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)
Applicant
Ciba Vision Corporation
PMA number
N17752
Supplement
S037
Product code
LPL
Generic name
Lenses, soft contact, daily 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.