PMA P870072S006

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S006
Product code: DSQ
Decision date: 1998-01-21
Classification: Ventricular (assist) Bypass
Generic name: Ventricular (assist) bypass
Approval order statement: Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb witha single-piece molded bulb.

Current openFDA PMA Record#

Device: THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM
Applicant: Thoratec Laboratories Corp.
PMA number: P870072
Supplement: S006
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 1998-01-21
Decision code: APPR
Date received: 1997-12-22
Supplement type: Normal 180 Day Track
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for 1) changing the thread sealant/thread locking material for the stinless steel pneumatic driveline fitting to the polysulfone VAD case cap from room temperature vulcanizing (RTV) silicone to Master Bond Polymer System EP21LV, and 2) replacing the current two-piece welded hand pump bulb witha single-piece molded bulb.