PMA P030002S009

Device: EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S009
Product code: NAA
Decision date: 2007-06-29
Generic name: Lens, intraocular, accommodative
Approval order statement: APPROVAL FOR RECOMMENDATION TO USE THE STAAR MSI-PF INJECTOR AND MTC-60C CARTRIDGE SYSTEM FOR INJECTING THE CRYSTALENS MODELS AT-45 & AT-45SE) TO BE ADDED TO THE PHYSICIAN LABELING.

Current openFDA PMA Record#

Device: EYEONICS CRYSTALENS MODEL AT-45 ACCOMMODATING INTRAOCULAR LENS (IOL)
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S009
Product code: NAA
Generic name: Lens, intraocular, accommodative
Decision date: 2007-06-29
Decision code: APPR
Date received: 2007-03-05
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR RECOMMENDATION TO USE THE STAAR MSI-PF INJECTOR AND MTC-60C CARTRIDGE SYSTEM FOR INJECTING THE CRYSTALENS MODELS AT-45 & AT-45SE) TO BE ADDED TO THE PHYSICIAN LABELING.