PMA P810002S120
- Device
- SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S120
- Product code
- LWQ
- Decision date
- 2023-10-18
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- A new sub-supplier for materials used in sutures
Current openFDA PMA Record#
- Device
- SJM™ Masters Series Mechanical Heart Valve, SJM Regent™ Mechanical Heart Valve, SJM™ Masters Series Aortic Valved Graft
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S120
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2023-10-18
- Decision code
- OK30
- Date received
- 2023-09-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- A new sub-supplier for materials used in sutures