LOTRAFILCON B SOFT CONTACT LENSES
FDA premarket approval P010019/S032 · decided 2012-05-22
Approval details
- PMA number
- P010019
- Supplement
- S032
- Supplement type
- 30-Day Notice
- Trade name
- LOTRAFILCON B SOFT CONTACT LENSES
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2012-05-04
- Decision date
- 2012-05-22
- Days to decision
- 18 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- ADDITION OF AN ALTERNATE RAW MATERIAL SUPPLIER FOR BETACON MACROMER USED IN THE FORMULATION OF LOTRAFILCON B SOFT CONTACT LENSES.
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