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 | FOCUS NIGHT & DAY (LOTRAFILCON A) SOFT CONTACT LENSES |
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 | P000030 |
Supplement Number | S002 |
Date Received | 02/26/2016 |
Decision Date | 03/23/2016 |
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 Manufacturing changes to include the installation and qualification of new (i.e., replacement) systems for the production of phosphate buffered saline and for the production of phosphate buffered saline with hydrogen peroxide at the Batam, Indonesia production facility. |
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