FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL
FDA premarket approval P830037/S048 · decided 2003-03-06
Approval details
- PMA number
- P830037
- Supplement
- S048
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/6 NIGHTS (SPHERICAL
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2003-02-07
- Decision date
- 2003-03-06
- Days to decision
- 27 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE FRESHLOOK DIMENSIONS (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENS INDICATED FOR EXTENDED WEAR UP TO 6 NIGHTS/7 DAYS. THIS DEVICE WILL BE AN OPTIMIZED COMBINATION OF TWO OF THE PREVIOUSLY APPROVED PROCESSES; NAMELY, CURRENT FRESHLOOK COLORBLENDS (MULTIPLE PRINT) PRINTING PROCESS (P830037/S045) AND THE FRESHLOOK HANDLING TINT MONOMER TINTING PROCESS (830037/S039). THIS ADDITIONAL PROCESS OF PRINTING ONTO A TINTED LENS FOR THE FRESHLOOK (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT L
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