PMA P240042S004
- Device
- Tendyne Transcatheter Mitral Valve System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P240042
- Supplement
- S004
- Product code
- NPU
- Decision date
- 2026-08-31
- Classification
- Cardiovascular
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Approval order statement
- to implement a supplier change for a component of the Tendyne Delivery System
Current openFDA PMA Record#
- Device
- Tendyne Transcatheter Mitral Valve System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P240042
- Supplement
- S004
- Product code
- NPU
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Decision date
- 2026-08-31
- Decision code
- OK30
- Date received
- 2026-08-04
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to implement a supplier change for a component of the Tendyne Delivery System