When did Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D receive FDA clearance or approval?

Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D (Submission ID: P010031) was fda approved by the U.S. FDA on 2026-10-29 under the PMA pathway with a review duration of 27 days.

Who is the manufacturer or applicant for Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D?

The applicant and sponsor for P010031 is Medtronic Cardiac Rhythm Disease Management.

Is P010031 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

Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D

Applicant: Medtronic Cardiac Rhythm Disease Management MDT

Statutory Profile

Legal Standard:

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

Product Code:

NIK

Review Panel:

Cardiovascular

21 CFR Regulation:

Unspecified

Review Velocity Metrics

Date Received:

2026-10-02

Decision Date:

2026-10-29

Total Review Duration:

27 calendar days (27 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

Marsha Seetaram

Role: US_AGENT

📞 904-2812763

✉️ marsha.n.seetaram@medtronic.com

Jason Einhorn

Role: US_AGENT

📞 888-4162409

✉️ jason@esutures.com

Carrie Schleis

Role: US_AGENT

📞 612-8101586

✉️ carrie.l.schleis@medtronic.com

Notice a discrepancy or outdated information on this record?

Report to support@fdacleared.org