FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
FDA premarket approval P010019/S001 · decided 2002-07-05
Approval details
- PMA number
- P010019
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Postapproval Study Protocol
- Trade name
- FOCUS NIGHT AND DAY (LOTRAFILCON A) SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2002-04-05
- Decision date
- 2002-07-05
- Days to decision
- 91 days
- Decision code
- APPR
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE REVISED POST-APPROVAL STUDY PROTOCOL FOR THE DEVICE. THE POST-APPROVAL STUDY PROTOCOL WAS SUBMITTED TO COMPLY WITH THE CONDITIONS OF APPROVAL OUTLINED IN THE OCTOBER 11, 2001 APPROVAL ORDER FOR P010019.
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510(k) clearances by this applicant
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