BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
FDA premarket approval P890023/S013 · decided 2002-03-11
Approval details
- PMA number
- P890023
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES FOR EXTENDED WEAR (UP TO 7 DAYS/6 NIGHTS OF EXTENDED WEAR)
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2002-01-18
- Decision date
- 2002-03-11
- Days to decision
- 52 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- APPROVAL FOR BIOMEDICS UV ASPHERE (OCUFILCON D) CONTACT LENSES INDICATED FOR EXTENDED WEAR (UP TO 7 DAYS/ 6 NIGHTS). THE SPONSOR ALSO REQUESTED APPROVAL OF THE SUBJECT DEVICES TO INCLUDE A STATEMENT THAT THE UV ABSORBING CONTACT LENSES HELP TO PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: THE BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CO
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