PMA P920014S011

Device: TCI HEARTMATE 1000A IP LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S011
Product code: DSQ
Decision date: 2000-07-20
Generic name: Ventricular (assist) bypass
Approval order statement: APPROVAL OF THE PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE FROM 2 YEARS TO 3 YEARS FOR PRODUCTS THAT ARE ETHYLENE OXIDE (EO) STERILIZED PER SPECIFICATION 24215 REV G IN THE FOLLOWING TYPES OF PACKAGING: BLISTER TRAY 0.040" PETG WITH TYVEK 1073B LID (COATED ONE SIDE WITH ADHESIVE) AND TYVEK POUCHES (INNER AND OUTER POUCHES) MADE WITH 1073B TYVEK, SEALED TO 48 GA PETG/2.0 MIL POLYETHYLENE.

Current openFDA PMA Record#

Device: TCI HEARTMATE 1000A IP LVAS
Applicant: Thoratec Corp
PMA number: P920014
Supplement: S011
Product code: DSQ
Generic name: Ventricular (assist) bypass
Decision date: 2000-07-20
Decision code: APPR
Date received: 2000-05-15
Supplement type: Normal 180 Day Track
Supplement reason: Other
Approval order statement: APPROVAL OF THE PROTOCOL TO BE USED TO EXTEND THE SHELF LIFE FROM 2 YEARS TO 3 YEARS FOR PRODUCTS THAT ARE ETHYLENE OXIDE (EO) STERILIZED PER SPECIFICATION 24215 REV G IN THE FOLLOWING TYPES OF PACKAGING: BLISTER TRAY 0.040" PETG WITH TYVEK 1073B LID (COATED ONE SIDE WITH ADHESIVE) AND TYVEK POUCHES (INNER AND OUTER POUCHES) MADE WITH 1073B TYVEK, SEALED TO 48 GA PETG/2.0 MIL POLYETHYLENE.