STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION

FDA premarket approval P990071/S016 · decided 2012-10-31

Approval details

PMA number

P990071

Supplement

S016

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION

Generic name

Cardiac ablation percutaneous catheter

Applicant

Biosense Webster, Inc.

Date received

2012-01-04

Decision date

2012-10-31

Days to decision

301 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR UPGRADING THE EXISTING ACCESSORY COOLFLOW IRRIGATION PUMP FOR THE STOCKERT 70 RADIOFREQUENCY (RF) GENERATOR FOR CARDIAC ABLATION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SMARTABLATE IRRIGATION PUMP AND SMARTABLATE TUBING SET. THE INDICATIONS ARE THAT THE SMARTABLATE IRRIGATION PUMP IS A PERISTALTIC PUMP DESIGNED TO WORK IN CONJUNCTION WITH THE STOCKERT 70 RADIOFREQUENCY GENERATOR TO DELIVER IRRIGATION SOLUTION AT SPECIFIED NOW RATES TO IRRIGATED CATHETERS (SUC

510(k) clearances by this applicant