PMA P040021S060
- Device
- Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max Stented Tissue Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S060
- Product code
- LWR
- Decision date
- 2025-10-30
- Classification
- Cardiovascular
- Generic name
- heart-valve, non-allograft tissue
- Approval order statement
- addition of two new porcine cusp tissue suppliers
Current openFDA PMA Record#
- Device
- Epic™, Epic™ Supra, Epic™ Plus, Epic™ Plus Supra and Epic™ Max Stented Tissue Valve
- Applicant
- ABBOTT MEDICAL
- PMA number
- P040021
- Supplement
- S060
- Product code
- LWR
- Generic name
- heart-valve, non-allograft tissue
- Decision date
- 2025-10-30
- Decision code
- OK30
- Date received
- 2025-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of two new porcine cusp tissue suppliers