PMA P010062S004

Device: RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S004
Product code: NUU
Decision date: 2006-05-30
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

Current openFDA PMA Record#

Device: RIGID GAS PERMEABLE CONTACT LENSES (BOSTON ORTHOKERATOLOGY)
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S004
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2006-05-30
Decision code: APPR
Date received: 2006-01-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS