PMA P060040S058
- Device
- THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S058
- Product code
- DSQ
- Decision date
- 2016-10-05
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for a relocation of a supplier.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S058
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-10-05
- Decision code
- APPR
- Date received
- 2016-04-26
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a relocation of a supplier.