PMA P870072S041
- Device
- THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S041
- Product code
- DSQ
- Decision date
- 2009-04-24
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- APPROVAL TO MODIFY THE LABELING TO INCLUDE POST-APPROVAL STUDY INFORMATION FOR THE IVAD SYSTEM.
Current openFDA PMA Record#
- Device
- THORATEC IMPLANTABLE VENTRICULAR ASSIST DEVICE (IVAD) SYSTEM
- Applicant
- Thoratec Laboratories Corp.
- PMA number
- P870072
- Supplement
- S041
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2009-04-24
- Decision code
- APPR
- Date received
- 2009-02-23
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO MODIFY THE LABELING TO INCLUDE POST-APPROVAL STUDY INFORMATION FOR THE IVAD SYSTEM.