BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE

FDA premarket approval P000020/S005 · decided 2001-11-21

Approval details

PMA number

P000020

Supplement

S005

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE

Generic name

Cardiac ablation percutaneous catheter

Applicant

Boston Scientific Corp

Date received

2001-09-24

Decision date

2001-11-21

Days to decision

58 days

Decision code

APPR

Product code

LPB

Advisory committee

Cardiovascular

Expedited review

No

Location

Lowell, MA

Statement

APPROVAL FOR USE OF THE BARD STINGER AND STINGER S ABLATION CATHETER AND TEMPLINK EXTENSION CABLE FOR USE WITH THE CORDIS STOCKERT 70W RF GENERATOR. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE SAME TRADE NAME AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.

510(k) clearances by this applicant