PMA P060040S067
- Device
- Thoratec, HeartMate II, Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S067
- Product code
- DSQ
- Decision date
- 2017-08-17
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Implement the use of a secondary supplier of three silicone components of the HeartMate II LVAS.
Current openFDA PMA Record#
- Device
- Thoratec, HeartMate II, Ventricular Assist System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S067
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-08-17
- Decision code
- OK30
- Date received
- 2017-07-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implement the use of a secondary supplier of three silicone components of the HeartMate II LVAS.