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 | Euclid Systems Orthokeratology (oprifoconA)/ Contact Lenses for Overnight Wear/Euclid Systems Orthokeratology (tisilfoco |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | Euclid Vision Corporation 45472 Holiday Drive Suite 7 Sterling, VA 20166 |
PMA Number | P040029 |
Supplement Number | S006 |
Date Received | 09/29/2017 |
Decision Date | 08/07/2019 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for new manufacturing site at Euclid Systems Corporation, 45472 Holiday Drive, Suite 7, Sterling, VA. |
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