PMA P810002S125
- Device
- Masters Series Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S125
- Product code
- LWQ
- Decision date
- 2025-10-15
- Classification
- Cardiovascular
- Generic name
- HEART-VALVE, MECHANICAL
- Approval order statement
- a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins
Current openFDA PMA Record#
- Device
- Masters Series Mechanical Heart Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P810002
- Supplement
- S125
- Product code
- LWQ
- Generic name
- HEART-VALVE, MECHANICAL
- Decision date
- 2025-10-15
- Decision code
- OK30
- Date received
- 2025-09-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the endotoxin extraction sample preparation method and to add the PyroGene endotoxin test method to detect bacterial endotoxins