PMA P990018S001

Device
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant
Menicon Co, Ltd.
PMA number
P990018
Supplement
S001
Product code
MWL
Decision date
2000-09-06
Classification
Lens, Contact (rigid Gas Permeable), Extended Wear
Generic name
Lens, contact (rigid gas permeable), extended wear
Approval order statement
APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.

Current openFDA PMA Record#

Device
MENICON Z (TISILFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Applicant
Menicon Co, Ltd.
PMA number
P990018
Supplement
S001
Product code
MWL
Generic name
Lens, contact (rigid gas permeable), extended wear
Decision date
2000-09-06
Decision code
APPR
Date received
2000-07-28
Supplement type
Normal 180 Day Track
Supplement reason
Postapproval Study Protocol
Approval order statement
APPROVAL OF PROCEDURES TO ADD LENS FINISHING LABORATORIES AS MANUFACTURERS AND DISTRIBUTORS OF CLASS III RGP EXTENDED WEAR CONTACT LENSES.