FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES
FDA premarket approval P830037/S042 · decided 1999-05-07
Approval details
- PMA number
- P830037
- Supplement
- S042
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL SOFT HYDROPHILIC CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 1999-04-07
- Decision date
- 1999-05-07
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for the following: 1) minor modification of the polymer formulation to include changes in the ratio of ingredients; 2) configuration change to include a bifocal design for the device; 3) modifications to the labeling to include the presbyopic indication and add the sentence "FreshLook(R) Lenses with UV-absorbing monomer help protect against the transmission of harmful UV radiation tot he cornea and into the eye"; 4) modification of the Note and Warning; 5) combining the package inserts
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