PMA P030023S002

Device
OPHTEC-STABLEYES CAPSULAR TENSION RING
Applicant
Ophtec BV
PMA number
P030023
Supplement
S002
Product code
MRJ
Decision date
2012-03-12
Classification
Ring, Endocapsular
Generic name
Ring, endocapsular
Approval order statement
APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.

Current openFDA PMA Record#

Device
OPHTEC-STABLEYES CAPSULAR TENSION RING
Applicant
Ophtec BV
PMA number
P030023
Supplement
S002
Product code
MRJ
Generic name
Ring, endocapsular
Decision date
2012-03-12
Decision code
APPR
Date received
2012-01-05
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL.