PMA P240042S003
- Device
- Tendyne™ Transcatheter Mitral Valve System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P240042
- Supplement
- S003
- Product code
- NPU
- Decision date
- 2026-08-07
- Classification
- Cardiovascular
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Approval order statement
- a packaging material change
Current openFDA PMA Record#
- Device
- Tendyne™ Transcatheter Mitral Valve System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P240042
- Supplement
- S003
- Product code
- NPU
- Generic name
- Prosthesis, mitral valve, percutaneously delivered
- Decision date
- 2026-08-07
- Decision code
- OK30
- Date received
- 2026-07-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a packaging material change