PMA P030002S024

Device: CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S024
Product code: NAA
Decision date: 2011-09-08
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO.

Current openFDA PMA Record#

Device: CRYSTLENS MODEL AT-45 ACCOMODATING INTROCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S024
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2011-09-08
Decision code: APPR
Date received: 2011-07-14
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO MODIFY THE LABELING TO INCLUDE THE ADDITION OF 0.25 DIOPTER INCREMENTS FOR THE +17 TO +27 POWER RANGE FOR THE CRYSTALENS ACCOMMODATING INTRAOCULAR LENS, MODEL AT52AO.