PMA P060040S032
- Device
- THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S032
- Product code
- DSQ
- Decision date
- 2014-03-18
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- REDUCTION IN POST-STERILIZATION HEATED AERATION TIME FOR SOME COMPONENTS.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE LEFT VENTRICULAR ASSIST SYSTEM DEVICE (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S032
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2014-03-18
- Decision code
- OK30
- Date received
- 2014-02-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REDUCTION IN POST-STERILIZATION HEATED AERATION TIME FOR SOME COMPONENTS.