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 | NIGHT & DAY 30 NIGHT EXTENDED WEAR SOFT CONTACT LENS |
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 | S002 |
Date Received | 02/24/2003 |
Decision Date | 03/19/2003 |
Product Code |
LPM |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE FOLLOWING INDICATION: NIGHT & DAY SOFT CONTACT LENSES ARE ALSO INDICATED FOR THERAPEUTIC USE. USE AS A BANDAGE TO PROTECT THE CORNEA AND TO RELIEVE CORNEAL PAIN DURING THE TREATMENT OF ACUTE OR CHRONIC OCULAR PATHOLOGIES SUCH AS BULLOUS KERATOPATHY, CORNEAL EROSIONS, ENTROPION, CORNEAL EDEMA, AND CORNEAL DYSTROPHIES AS WELL AS POST-SURGICAL CONDITIONS RESULTING FROM CATARACT EXTRACTION AND CORNEAL SURGERY. NIGHT & DAY SOFT CONTACT LENSES FOR THERAPEUTIC USE CAN ALSO PROVIDE OPTICAL CORRECTION DURING HEALING IF REQUIRED. |
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