PMA P010059S011

Device
MORCHER® Capsular Tension Rings
Applicant
Morcher GmbH
PMA number
P010059
Supplement
S011
Product code
MRJ
Decision date
2023-09-06
Classification
Ophthalmic
Generic name
Ring, endocapsular
Approval order statement
Approval for improved instructions for use labeling.

Current openFDA PMA Record#

Device
MORCHER® Capsular Tension Rings
Applicant
Morcher GmbH
PMA number
P010059
Supplement
S011
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2023-09-06
Decision code
APPR
Date received
2023-08-07
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for improved instructions for use labeling.