PMA P870072S039

Device: THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S039
Product code: DSQ
Decision date: 2008-01-31
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO REVISE THE IVAD INSTRUCTIONS FOR USE TO DELETE THE REFERENCE TO PARACORPOREAL PLACEMENT OF THE IVAD AND INDICATE THAT THE IVAD SHOULD BE CONTRAINDICATED FOR THE PARACORPOREAL PLACEMENT.

Current openFDA PMA Record#

Device: THORATEC IMPLANTATION VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S039
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2008-01-31
Decision code: APPR
Date received: 2007-12-27
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO REVISE THE IVAD INSTRUCTIONS FOR USE TO DELETE THE REFERENCE TO PARACORPOREAL PLACEMENT OF THE IVAD AND INDICATE THAT THE IVAD SHOULD BE CONTRAINDICATED FOR THE PARACORPOREAL PLACEMENT.