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 | VIEWPOINT CK SYSTEM |
Generic Name | Electrosurgical, radio frequency, refractive correction |
Applicant | REFRACTEC, INC. 5 JENNER, SUITE 150 IRVINE, CA 92618 |
PMA Number | P010018 |
Supplement Number | S003 |
Date Received | 07/10/2003 |
Decision Date | 11/06/2003 |
Product Code |
MWD |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR UPDATING THE LABELING WITH THE 24 MONTH CLINICAL STUDY RESULTS. |
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