PMA P010062S008

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S008
Product code: NUU
Decision date: 2014-07-28
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).

Current openFDA PMA Record#

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S008
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2014-07-28
Decision code: APPR
Date received: 2010-10-20
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING UPDATE TO THE PACKAGE INSERT AND PATIENT INFORMATION BOOKLET TO INCLUDE THE RESULTS FROM A SECTION 522 POSTMARKET SURVEILLANCE STUDY (PAS).