PMA P920014S009
- Device
- HEARTMATE IP & VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S009
- Product code
- DSQ
- Decision date
- 1999-08-10
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL(TM).
Current openFDA PMA Record
- Device
- HEARTMATE IP & VE LVAS
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S009
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 1999-08-10
- Decision code
- APPR
- Date received
- 1999-07-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to change the material of the retaining suture that TCI includes with each implant kit from Tevdek II 7-776 to #2 NOVAFIL(TM).