STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

FDA premarket approval P990071/S002 · decided 2002-02-15

Approval details

PMA number

P990071

Supplement

S002

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

STOCKERT 70 RADIOFREQUENCY ABLATION GENERATOR

Generic name

CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Applicant

Biosense Webster, Inc.

Date received

2001-11-29

Decision date

2002-02-15

Days to decision

78 days

Decision code

APPR

Product code

DRF

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR 1) ADAPTER CABLES (MODELS D-1170-27-001, D-1170-28-001, AND D-1170-29-001) THAT CONNECT THE STOCKERT 70 RF GENERATOR CABLE TO COMPATIBLE CATHETERS AND 2) A NEW INDICATIONS FOR USE FOR THE STOCKERT 70 RF GENERATOR. THE ADAPTER CABLES WILL BE MARKETED UNDER THE TRADE NAME STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION. BOTH THE STOCKERT 70 RF GENERATOR CABLE ADAPTERS FOR CARDIAC ABLATION AND STOCKERT 70 RF GENERATOR ARE INDICATED FOR USE IN CONJUNCTION WITH A COMPATIBLE

510(k) clearances by this applicant