PMA P060040S061
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S061
- Product code
- DSQ
- Decision date
- 2016-11-17
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Manufacturing process change from a manual to a semi-automatic application of adhesive during the assembly of the battery clip.
Current openFDA PMA Record#
- Device
- THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S061
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2016-11-17
- Decision code
- OK30
- Date received
- 2016-10-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacturing process change from a manual to a semi-automatic application of adhesive during the assembly of the battery clip.