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.