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 | RayOne EMV (Model RAO200E) |
Applicant | RAYNER INTRAOCULAR LENSES LTD. 1-2 SACKVILLE TRADING ESTATE, SACKVILLE ROAD HOVE, EAST SUSSEX BN3 7 |
PMA Number | P060011 |
Supplement Number | S025 |
Date Received | 08/14/2020 |
Decision Date | 03/26/2021 |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement Approval for the RayOne EMV, Model RAO200E, which is a preloaded intraocular lens (IOL) injector system extending the RayOne family of one-piece IOLs that incorporate an optical modification. |
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