PMA P010062S002

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S002
Product code: NUU
Decision date: 2004-12-03
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order 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.

Current openFDA PMA Record#

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSH & LOMB VISION SHAPING TREATMENT
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S002
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2004-12-03
Decision code: APPR
Date received: 2004-09-01
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order 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.