PMA P980040S037

Device: AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S037
Product code: HQL
Decision date: 2012-04-23
Classification: Intraocular Lens
Generic name: intraocular lens
Approval order statement: APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.

Current openFDA PMA Record#

Device: AMO SENSAR SOFT ACRYLIC INTRAOCULAR LENSES (IOL) (MODELS AR40E/AR40E/AR40M/AR40MN) & TECNIS 1 PIECE INTRAOCULAR LENS
Applicant: Johnson & Johnson Surgical Vision, Inc.
PMA number: P980040
Supplement: S037
Product code: HQL
Generic name: intraocular lens
Decision date: 2012-04-23
Decision code: APPR
Date received: 2011-11-14
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A CHANGE IN THE TEST METHOD USED TO DETERMINE BACTERIAL ENDOTOXIN LEVELS OF INTRAOCULAR LENSES.