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 | BIOCURVE SOFT CONTACT LENSES |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | WAVETOUCH TECHNOLOGIES, LLC 15970 BERNARDO CENTER DR. SAN DIEGO, CA 92127 |
PMA Number | P860040 |
Supplement Number | S016 |
Date Received | 05/05/2004 |
Decision Date | 05/28/2004 |
Product Code |
LPM |
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 TO RELOCATE SOME MANUFACTURING PROCESSES TO THE SITE LOCATED AT AMERICAN BIOCURVE, INC., SAN DIEGO, CALIFORNIA. |
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