PMA P160054S033
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S033
- Product code
- DSQ
- Decision date
- 2021-01-07
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Addition of an alternate sub-tier supplier for the Integrated Motor Control (IMC) printed circuit board assembly.
Current openFDA PMA Record#
- Device
- HeartMate 3™ Left Ventricular Assist System (LVAS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P160054
- Supplement
- S033
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2021-01-07
- Decision code
- OK30
- Date received
- 2020-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternate sub-tier supplier for the Integrated Motor Control (IMC) printed circuit board assembly.