PMA P060040S128
- Device
- HeartMate II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S128
- Product code
- DSQ
- Decision date
- 2026-10-01
- Classification
- Cardiovascular
- Generic name
- Ventricular (assist) bypass
- Approval order statement
- addition of new top case critical dimensions to be measured and a new measurement gauge
Current openFDA PMA Record#
- Device
- HeartMate II LVAS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P060040
- Supplement
- S128
- Product code
- DSQ
- Generic name
- Ventricular (assist) bypass
- Decision date
- 2026-10-01
- Decision code
- OK30
- Date received
- 2026-09-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of new top case critical dimensions to be measured and a new measurement gauge