WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
FDA premarket approval P020050/S001 · decided 2004-06-04
Approval details
- PMA number
- P020050
- Supplement
- S001
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Express GMP Supplement
- Trade name
- WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2004-05-21
- Decision date
- 2004-06-04
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT WAVELIGHT LASER TECHNOLOGIE AG, PRESSATH, GERMANY.
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