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 | CIBA VISION LOTRAFILCON B SOFT CONTACT LENSES FOR EXTENDED WEAR |
Generic Name | Lenses, soft contact, extended wear |
Regulation Number | 886.5925 |
Applicant | Alcon Laboratories, Inc. 6201 South Freeway Fort Worth, TX 76134-2099 |
PMA Number | P010019 |
Supplement Number | S024 |
Date Received | 04/21/2011 |
Decision Date | 05/18/2011 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGE IN THE SECONDARY PACKAGING SIDE LASER PRINTING INSPECTION SYSTEM. |
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