PMA P060040S053
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S053
- Product code
- DSQ
- Decision date
- 2016-03-24
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Qualify a second source supplier for molded parts used in the HeartMate II System.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S053
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-03-24
- Decision code
- OK30
- Date received
- 2016-02-26
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Qualify a second source supplier for molded parts used in the HeartMate II System.