PMA P870072S055
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD)
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S055
- Product code
- DSQ
- Decision date
- 2013-12-10
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL OF THE ADDITION OF A PVAD ISOLATION MODULE (PIM) FOR USE WITH THE PVAD AND THE DUAL DRIVE CONSOLE (DDC).
Current openFDA PMA Record#
- Device
- THORATEC VENTRICULAR ASSIST DEVICE (VAD)
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S055
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2013-12-10
- Decision code
- APPR
- Date received
- 2013-07-02
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF THE ADDITION OF A PVAD ISOLATION MODULE (PIM) FOR USE WITH THE PVAD AND THE DUAL DRIVE CONSOLE (DDC).