MOBILEXCIMER FOR PTK AND PRK
FDA premarket approval P960019/S001 · decided 1997-04-07
Approval details
- PMA number
- P960019
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MOBILEXCIMER FOR PTK AND PRK
- Generic name
- Excimer laser system
- Applicant
- Laser Vision Centers, Inc.
- Date received
- 1996-11-22
- Decision date
- 1997-04-07
- Days to decision
- 136 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- St. Louis, MO
- Statement
- APPROVAL FOR THE LASERVISION(R)/VISX EXCIMER LASER SYSTEM MODEL C FOR PTK AND PRK TO BE INSTALLED IN THE CALUMET COACH MODEL MMT-436V SEMI-TRAILER COACH, WHICH WILL BE MANUFACTURED BY THE CALUMET COACH COMPANY, 2150 E.DALTON RD., CALUMET CITY, IL 60409-1411. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME MOBILEXCIMER(R) FOR PHOTOTHERAPEUTIC KERATECTOMY (PTK) AND PHOTOREFRACTIVE KERATECTOMY (PRK) THE DEVICE INDICATIONS REMAINED THE SAME
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