BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
FDA premarket approval P010062/S005 · decided 2007-02-01
Approval details
- PMA number
- P010062
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Bausch & Lomb
- Date received
- 2006-12-21
- Decision date
- 2007-02-01
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- Statement
- APPROVAL FOR REMOVING UNIVAL D-49 FROM THE FORMULATION FOR OPRIFOCON A, AND THE REQUESTED LABELING CHANGES.
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