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 | 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 | S074 |
Date Received | 11/13/2019 |
Decision Date | 12/12/2019 |
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 Extension of the lotrafilcon B soft contact lens manufacturing operations at the Alcon Batam, Indonesia production site for inclusion of AIR OPTIX plus Hydraglyde (lotrafilcon B) spherical soft contact lenses. |
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