|
Device | CustomFlex Artificial Iris |
Generic Name | Artificial iris |
Applicant | HumanOptics AG Spardorfer Strasse 150 Erlangen 91054 |
PMA Number | P170039 |
Supplement Number | S001 |
Date Received | 07/10/2018 |
Decision Date | 09/23/2019 |
Product Code |
QBT |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01860612
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the protocol for the post-approval study (PAS) protocol. |