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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceBIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
Generic NameLenses, soft contact, extended wear
Regulation Number886.5925
ApplicantCooperVision, Inc.
6101 Bollinger Canyon Rd.
Suite 500
San Ramon, CA 94583
PMA NumberP080011
Supplement NumberS035
Date Received12/16/2014
Decision Date03/11/2015
Product Code LPM 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A CHANGE IN TRADE NAME FOR THE BIOFINITY ENERGYS ASPHERIC LENS AND EXPANDED POWERS FOR THE BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, AND BIOFINITY XR MULTIFOCAL (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOREXTENDED WEAR AND ARE INDICATED FOR: BIOFINITY ENERGYS ASPHERE (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY XR TORIC (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND ASTIGMATISM CORRECTIONS FROM -0.25 TO -5.75 D.BIOFINITY XR MULTIFOCAL (COMFILCON A) LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) WITH EMMETROPIA WITH PRESBYOPIA IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND WITH ADD POWERS FROM +0.05 TO +4.00 D. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBITASTIGMATISM OF 2.00 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.
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