TAP SYSTEM 2A

System, Esophageal Pacing

FDA Premarket Approval P840002 S013

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Approval for a manufacturing site located at cardiocommand, inc. , in tampa, florida, for the manufacture of the tapsystem model 2a device.

• Device: TAP SYSTEM 2A
• Classification Name: System, Esophageal Pacing
• Generic Name: System, Esophageal Pacing
• Applicant: CARDIOCOMMAND, INC.
• Date Received: 2015-05-28
• Decision Date: 2016-03-24
• PMA: P840002
• Supplement: S013
• Product Code: LPA
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: CARDIOCOMMAND, INC. 4920 West Cypress Street suite 110 tampa, FL 33607-3837

Supplemental Filings

Supplement Number	Date	Supplement Type
P840002		Original Filing
S013	2015-05-28	Normal 180 Day Track No User Fee
S012	2004-06-04	Real-time Process
S011	2004-03-09	Normal 180 Day Track No User Fee
S010	2004-01-16	Normal 180 Day Track No User Fee
S009	1997-01-21	Normal 180 Day Track
S008	1996-01-03	Normal 180 Day Track
S007	1995-10-02	Normal 180 Day Track
S006
S005
S004
S003
S002
S001	1993-07-12	Normal 180 Day Track

NIH GUDID Devices

Device ID	PMA	Supp
00856233005073	P840002	000
00856233005158	P840002	007
00856233005066	P840002	007