PMA P060040S066
- Device
- HeartMate II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S066
- Product code
- DSQ
- Decision date
- 2017-04-11
- Classification
- Ventricular (assist) Bypass
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- Approval for revisions to the warning statement related to body surface area (BSA) in the HeartMate II LVAS labeling.
Current openFDA PMA Record#
- Device
- HeartMate II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S066
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2017-04-11
- Decision code
- APPR
- Date received
- 2017-02-14
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for revisions to the warning statement related to body surface area (BSA) in the HeartMate II LVAS labeling.