SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A

Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)

ST. JUDE MEDICAL

The following data is part of a premarket notification filed by St. Jude Medical with the FDA for Sjm Confirm Icm, Model Drm2100, Sjm Confirm Pa, Model Dm2100a.

Pre-market Notification Details

• Device ID: K101968
• 510k Number: K101968
• Device Name: SJM CONFIRM ICM, MODEL DRM2100, SJM CONFIRM PA, MODEL DM2100A
• Classification: Recorder, Event, Implantable Cardiac, (without Arrhythmia Detection)
• Applicant: ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527
• Contact: Susan Engelson
• Correspondent: Susan Engelson; ST. JUDE MEDICAL 701 EAST EVELYN AVENUE Sunnyvale, CA 94086 -6527
• Product Code: MXC
• CFR Regulation Number: 870.2800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-07-12
• Decision Date: 2010-09-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
05414734502696	K101968	000
05414734502597	K101968	000