BIOFINITY (COMFILCON A)
FDA premarket approval P080011 · decided 2008-11-19
Approval details
- PMA number
- P080011
- Trade name
- BIOFINITY (COMFILCON A)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2008-04-07
- Decision date
- 2008-11-19
- Days to decision
- 226 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- APPROVAL FOR THEBIOFINITY (COMFILCON A) SOFT CONTACT LENS. THIS DEVICE IS INDICATED FOR USE AS FOLLOWS:BIOFINITY (COMFILCON A) SPHERE AND ASPHERC SOFT CONTACT LENSES ARE INDICATED FOR THECORRECTION 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 BYPERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITHVISUAL ACUITY.BIOFINITY (COMFILCON A) TORIC SOFT CONTACT
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