PMA P870072S004

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S004
Product code: DSQ
Decision date: 1997-07-10
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for changing the test methodology for measuring molecualr weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.

Current openFDA PMA Record#

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S004
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1997-07-10
Decision code: APPR
Date received: 1997-05-28
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for changing the test methodology for measuring molecualr weight of BPS-215 from gel permeation chromatography to intrinsic viscosity during the manufacturing process.