PMA P920014S004
- Device
- TCI HEARTMATE(R) 1000A IP LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S004
- Product code
- DSQ
- Decision date
- 1996-03-13
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL FOR REVISING THE LABELING TO DELETE THE HEMODYNAMIC CRITERIA FROM THE INDICATIONS FOR USE
Current openFDA PMA Record#
- Device
- TCI HEARTMATE(R) 1000A IP LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S004
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1996-03-13
- Decision code
- APPR
- Date received
- 1995-12-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR REVISING THE LABELING TO DELETE THE HEMODYNAMIC CRITERIA FROM THE INDICATIONS FOR USE