PMA P030023S006

Device
RingJect
Applicant
Ophtec BV
Product code
MRJ
Decision date
2019-04-30
Generic name
Ring, endocapsular
Approval order statement
Approval for design changes and a new supplier, Elbo Technics, for the RingJect.

Current openFDA PMA Record#

Device
RingJect
Applicant
Ophtec BV
PMA number
P030023
Supplement
S006
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2019-04-30
Decision code
APPR
Date received
2018-05-04
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for design changes and a new supplier, Elbo Technics, for the RingJect.