PMA P060040S046

Device: HEARTMATE II LVAS SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S046
Product code: DSQ
Decision date: 2015-10-19
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE REGARDING CHECKING THE EXPIRATION DATE OF AND REPLACING THE BACKUP BATTERY CONTAINED ON THE POCKET CONTROLLER.

Current openFDA PMA Record#

Device: HEARTMATE II LVAS SYSTEM
Applicant: ABBOTT MEDICAL
PMA number: P060040
Supplement: S046
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2015-10-19
Decision code: APPR
Date received: 2015-10-08
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR REVISIONS TO THE INSTRUCTIONS FOR USE REGARDING CHECKING THE EXPIRATION DATE OF AND REPLACING THE BACKUP BATTERY CONTAINED ON THE POCKET CONTROLLER.