BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
FDA premarket approval P010062/S002 · decided 2004-12-03
Approval details
- PMA number
- P010062
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Bausch & Lomb
- Date received
- 2004-09-01
- Decision date
- 2004-12-03
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL TO REVISE THE PROFESSIONAL FITTING AND INFORMATION GUIDE PRODUCT LABELING TO INCLUDE FITTING GUIDELINES FOR CORNEAL TOPOGRAPHY-BASED FITTING METHODS AND OTHER MINOR CHANGES AND GRAMMATICAL CORRECTIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE SAME PRIOR APPROVED INDICATIONS FOR USE.
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