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PMA P780007S060

Device
Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S060
Product code
LPM
Decision date
2018-06-01
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for 1) Removal of assay (% NaCl) test requirement from the in-process packaging solution specification; and 2) Addition of osmolality specification to the post-autoclave packaging solution specification.

Current openFDA PMA Record#

Device
Biomedics38 (polymacon) Soft (Hydrophilic) Extended Wear Contact Lenses
Applicant
CooperVision, Inc.
PMA number
P780007
Supplement
S060
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-06-01
Decision code
APPR
Date received
2018-03-05
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for 1) Removal of assay (% NaCl) test requirement from the in-process packaging solution specification; and 2) Addition of osmolality specification to the post-autoclave packaging solution specification.