PMA P190023S001

Device: Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S001
Product code: NPT
Decision date: 2021-11-12
Generic name: Aortic valve, prosthesis, percutaneously delivered
Approval order statement: Approval of the protocol for the Post Approval Study "Registry-Based Real World Use Surveillance of the Portico TAVI System."

Current openFDA PMA Record#

Device: Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System
Applicant: ABBOTT MEDICAL
PMA number: P190023
Supplement: S001
Product code: NPT
Generic name: Aortic valve, prosthesis, percutaneously delivered
Decision date: 2021-11-12
Decision code: APPR
Date received: 2021-10-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval of the protocol for the Post Approval Study "Registry-Based Real World Use Surveillance of the Portico TAVI System."