|
Device | OPHTEC-STABLEYES CAPSULAR TENSION RING |
Generic Name | Ring, endocapsular |
Applicant | OPHTEC BV Schweitzerlaan 15 Groningen 9728 |
PMA Number | P030023 |
Supplement Number | S002 |
Date Received | 01/05/2012 |
Decision Date | 03/12/2012 |
Product Code |
MRJ |
Advisory Committee |
Ophthalmic |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A NEW SUPPLIER OF A CRITICAL RAW MATERIAL. |