NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

FDA premarket approval P010068 · decided 2002-09-27

Approval details

PMA number

P010068

Trade name

NAVISTAR/CELSIUS DS DIAGNOSTIC/ABLATION DEFLECTABLE 8MM TIP CATHETER

Generic name

catheter, percutaneous, cardiac ablation, for treatment of atrial flutter

Applicant

Biosense Webster, Inc.

Date received

2001-12-31

Decision date

2002-09-27

Days to decision

270 days

Decision code

APPR

Product code

OAD

Advisory committee

Cardiovascular

Expedited review

No

Location

Irvine, CA

Statement

APPROVAL FOR THE NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS, STOCKERT 70 GENERATOR AND ACCESSORIES. THE NAVISTAR DS AND CELSIUS DS CATHETERS AND RELATED ACCESSORY DEVICES ARE INDICATED FOR CATHETER-BASED CARDIAC ELECTROPHYSIOLOGICAL MAPPING (STIMULATION AND RECORDING), AND FOR USE WITH THE STOCKERT 70 (MODEL S7001 WITH SOFTWARE VERSION 001/033) FOR THE TREATMENT OF TYPE I ATRIAL FLUTTER IN PATIENTS AGE 18 OR OLDER. THE NAVISTAR DS CATHETER PROVIDES LOCATION INFORMATION WHEN USED WI

510(k) clearances by this applicant