PMA P240042S001

Device: Tendyne™ Transcatheter Mitral Valve
Applicant: ABBOTT MEDICAL
PMA number: P240042
Supplement: S001
Product code: NPU
Decision date: 2025-07-29
Classification: Cardiovascular
Generic name: Prosthesis, mitral valve, percutaneously delivered
Approval order statement: two changes to the EO sterilization of components, processing aids, and Jar Set Assemblies (JSAs) - an addition of a duplicate sterilization chamber at an existing sterilization site, and the addition of an alternate sterilization facility

Current openFDA PMA Record#

Device: Tendyne™ Transcatheter Mitral Valve
Applicant: ABBOTT MEDICAL
PMA number: P240042
Supplement: S001
Product code: NPU
Generic name: Prosthesis, mitral valve, percutaneously delivered
Decision date: 2025-07-29
Decision code: OK30
Date received: 2025-06-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: two changes to the EO sterilization of components, processing aids, and Jar Set Assemblies (JSAs) - an addition of a duplicate sterilization chamber at an existing sterilization site, and the addition of an alternate sterilization facility