ALLEGRETTO WAVE EYE-Q
FDA premarket approval P020050/S024 · decided 2015-10-15
Approval details
- PMA number
- P020050
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALLEGRETTO WAVE EYE-Q
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2015-07-29
- Decision date
- 2015-10-15
- Days to decision
- 78 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR LABELING REVISIONS TO ADDRESS DESIGN CHANGE.
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