PMA P010062S005
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S005
- Product code
- NUU
- Decision date
- 2007-02-01
- Classification
- Lens, Contact, Orthokeratology, Overnight
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- APPROVAL FOR REMOVING UNIVAL D-49 FROM THE FORMULATION FOR OPRIFOCON A, AND THE REQUESTED LABELING CHANGES.
Current openFDA PMA Record#
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S005
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2007-02-01
- Decision code
- APPR
- Date received
- 2006-12-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR REMOVING UNIVAL D-49 FROM THE FORMULATION FOR OPRIFOCON A, AND THE REQUESTED LABELING CHANGES.