When did Navitor Transcatheter Aortic Valve Implantation System receive FDA clearance or approval?

Navitor Transcatheter Aortic Valve Implantation System (Submission ID: P190023) was fda approved by the U.S. FDA on 2026-10-29 under the PMA pathway with a review duration of 170 days.

Who is the manufacturer or applicant for Navitor Transcatheter Aortic Valve Implantation System?

The applicant and sponsor for P190023 is ABBOTT MEDICAL.

Is P190023 an AI/ML-enabled medical device?

No. This medical device submission is not designated as incorporating AI/ML software algorithms.

FDA Approved Existing Device (Modification) Pathway: PMA

Navitor Transcatheter Aortic Valve Implantation System

Applicant: ABBOTT MEDICAL ABT

Statutory Profile

Legal Standard:

Reasonable assurance of safety and effectiveness (Section 515 FD&C Act)

Product Code:

NPT

Review Panel:

Cardiovascular

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-05-12

Decision Date:

2026-10-29

Total Review Duration:

170 calendar days (170 days)

Official FDA Research Backlinks

Direct links to primary official records hosted by the U.S. Food and Drug Administration CDRH databases:

FDA Database Webpage (pmn.cfm) Official Decision Summary PDF Product Classification Database Establishment Registration & Listing

Identified Contacts & Correspondents

Roberta Bogenschutz

Role: US_AGENT

📞 651-3926296

✉️ roberta.bogenschutz@abbott.com

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