Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | MORCHER® Capsular Tension Rings |
Generic Name | Ring, endocapsular |
Applicant | MORCHER GMBH KAPUZINERWEG 12 STUTTGART, WURTTEMBERG-BADEN D-703-7037 |
PMA Number | P010059 |
Supplement Number | S011 |
Date Received | 08/07/2023 |
Decision Date | 09/06/2023 |
Product Code |
MRJ |
Advisory Committee |
Ophthalmic |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for improved instructions for use labeling. |
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