PMA P030023S005

Device
RINGJECT
Applicant
Ophtec BV
PMA number
P030023
Supplement
S005
Product code
MRJ
Decision date
2016-07-06
Classification
Ring, Endocapsular
Generic name
Ring, endocapsular
Approval order statement
Modification of the current blunt finish distal tip on capsular tension ring (CTR) injector to an angular (beveled) distal tip finish.

Current openFDA PMA Record#

Device
RINGJECT
Applicant
Ophtec BV
PMA number
P030023
Supplement
S005
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2016-07-06
Decision code
OK30
Date received
2016-06-10
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Modification of the current blunt finish distal tip on capsular tension ring (CTR) injector to an angular (beveled) distal tip finish.