CareLink SmartSync Device Manager - Pacing System Analyzer

Tester, Pacemaker Electrode Function

Medtronic, Inc.

The following data is part of a premarket notification filed by Medtronic, Inc. with the FDA for Carelink Smartsync Device Manager - Pacing System Analyzer.

Pre-market Notification Details

• Device ID: K163008
• 510k Number: K163008
• Device Name: CareLink SmartSync Device Manager - Pacing System Analyzer
• Classification: Tester, Pacemaker Electrode Function
• Applicant: Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Contact: Laura Danielson
• Correspondent: Laura Danielson; Medtronic, Inc. 8200 Coral Sea Street NE Mounds View, MN 55112
• Product Code: DTA
• CFR Regulation Number: 870.3720 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-10-28
• Decision Date: 2017-02-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00643169868540	K163008	000
00643169833753	K163008	000
00643169833739	K163008	000
00643169833715	K163008	000