PMA P870072S040

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S040
Product code: DSQ
Decision date: 2008-10-31
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL TO STRENGTHEN THE IVAD Y-CONNECTOR TERMINATION BY ADDING A SMALL AMOUNT (35 UL) OF SILICONE OIL TO THE INNER WALL OF THE PNEUMATIC LINE TO REDUCE THE TRANSFERABLE FORCE BETWEEN THE IVAD OPTICAL SENSOR CABLE AND THE PNEUMATIC LINE WALL.

Current openFDA PMA Record#

Device: THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S040
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2008-10-31
Decision code: APPR
Date received: 2008-04-21
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL TO STRENGTHEN THE IVAD Y-CONNECTOR TERMINATION BY ADDING A SMALL AMOUNT (35 UL) OF SILICONE OIL TO THE INNER WALL OF THE PNEUMATIC LINE TO REDUCE THE TRANSFERABLE FORCE BETWEEN THE IVAD OPTICAL SENSOR CABLE AND THE PNEUMATIC LINE WALL.