PMA P030023S011

Device
Capsular Tension Ring (CTR)
Applicant
Ophtec BV
PMA number
P030023
Supplement
S011
Product code
MRJ
Decision date
2024-01-18
Classification
Ophthalmic
Generic name
Ring, endocapsular
Approval order statement
a change to the supplier of the packaging Tyvek lid

Current openFDA PMA Record#

Device
Capsular Tension Ring (CTR)
Applicant
Ophtec BV
PMA number
P030023
Supplement
S011
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2024-01-18
Decision code
OK30
Date received
2023-12-21
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
a change to the supplier of the packaging Tyvek lid