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 | S004 |
Date Received | 07/16/2003 |
Decision Date | 07/31/2003 |
Product Code |
MWD |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Express GMP Supplement |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR AN ALTERNATE MANUFACTURING FACILITY FOR THE SUB-ASSEMBLY OF THE RCS-300 CONSOLE. THE MANUFACTURING FACILITY IS LOCATED AT REFRACTEC, INC., IRVINE, CALIFORNIA. |
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