PMA P010062S003
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S003
- Product code
- NUU
- Decision date
- 2006-02-21
- Classification
- Lens, Contact, Orthokeratology, Overnight
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- APPROVAL OF REVISIONS TO THE POST-APPROVAL REGRESSION ANALYSIS PROTOCOL.
Current openFDA PMA Record#
- Device
- BOSTON ORTHOKERATOLOGY (OPRIFOCON A)SHAPING LENS FOR OVERNIGHT WEAR
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S003
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2006-02-21
- Decision code
- APPR
- Date received
- 2005-04-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF REVISIONS TO THE POST-APPROVAL REGRESSION ANALYSIS PROTOCOL.