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 AND 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 | P010019 |
Supplement Number | S001 |
Date Received | 04/05/2002 |
Decision Date | 07/05/2002 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE. THE POST-APPROVAL STUDY PROTOCOL WAS SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE OCTOBER 11, 2001 APPROVAL ORDER FOR P010019. |
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