PMA P010068S007

Device: NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS
Applicant: Biosense Webster, Inc.
PMA number: P010068
Supplement: S007
Product code: OAD
Decision date: 2005-10-21
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: APPROVAL FOR ALTERNATE STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, SAN DIEGO, CALIFORNIA, FOR THE INTERFACE CABLES (PART NUMBERS D-1195-XX) FOR ABLATION CATHETERS.

Current openFDA PMA Record#

Device: NAVISTAR DS AND CELSIUS DS DIAGNOSTIC/ABLATION CATHETERS
Applicant: Biosense Webster, Inc.
PMA number: P010068
Supplement: S007
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2005-10-21
Decision code: APPR
Date received: 2005-09-22
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR ALTERNATE STERILIZATION SITE LOCATED AT STERIS ISOMEDIX SERVICES, SAN DIEGO, CALIFORNIA, FOR THE INTERFACE CABLES (PART NUMBERS D-1195-XX) FOR ABLATION CATHETERS.