PMA P030002S037

Device: CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S037
Product code: MJP
Decision date: 2016-02-09
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Approval order statement: Approval of the following changes to the post-approval study for the device: administrative changes, including changes to personnel and organization and changes to the informed consent form.

Current openFDA PMA Record#

Device: CRYSTALENS AND TRULIGN TORIC POSTERIOR CHAMBER INTRAOCULAR LENS
Applicant: Bausch & Lomb, Inc.
PMA number: P030002
Supplement: S037
Product code: MJP
Generic name: LENS, INTRAOCULAR, TORIC OPTICS
Decision date: 2016-02-09
Decision code: APPR
Date received: 2015-12-18
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol - OSB
Approval order statement: Approval of the following changes to the post-approval study for the device: administrative changes, including changes to personnel and organization and changes to the informed consent form.