PMA P920014S027
- Device
- HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S027
- Product code
- DSQ
- Decision date
- 2007-06-29
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- ALTERNATE SUPPLIER FOR THE POLYMER USED TO MANUFACTURE THE DIAPHRAGM USED IN THE DEVICE.
Current openFDA PMA Record#
- Device
- HEARTMATE XVE LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- Thoratec Corp
- PMA number
- P920014
- Supplement
- S027
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2007-06-29
- Decision code
- OK30
- Date received
- 2007-05-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ALTERNATE SUPPLIER FOR THE POLYMER USED TO MANUFACTURE THE DIAPHRAGM USED IN THE DEVICE.