PMA P060040S034
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S034
- Product code
- DSQ
- Decision date
- 2014-04-09
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- ADDITION OF A SECOND SUPPLIER FOR THE EMERGENCY BACKUP BATTERY (EBB).
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S034
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-04-09
- Decision code
- OK30
- Date received
- 2014-03-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A SECOND SUPPLIER FOR THE EMERGENCY BACKUP BATTERY (EBB).