PMA P780010S020

Device
PERMLENS
Applicant
CooperVision, Inc.
PMA number
P780010
Supplement
S020
Product code
LPM
Decision date
1998-12-04
Generic name
Lenses, soft contact, extended wear
Approval order statement
Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.

Current openFDA PMA Record#

Device
PERMLENS
Applicant
CooperVision, Inc.
PMA number
P780010
Supplement
S020
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
1998-12-04
Decision code
APPR
Date received
1998-10-28
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for a ten (10) year expiration date for the Permalens (perfilcon A) Hydrophilic contact lenses. The device, as modified, will be marketed under the trade name as referenced above with no change in the current indications.