PMA P060040S043
- Device
- THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S043
- Product code
- DSQ
- Decision date
- 2015-08-20
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- QUALIFY AN ALTERNATE MANUFACTURING SITE FOR THE BEND RELIEF OF THE CANNULA.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S043
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2015-08-20
- Decision code
- OK30
- Date received
- 2015-07-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- QUALIFY AN ALTERNATE MANUFACTURING SITE FOR THE BEND RELIEF OF THE CANNULA.