PMA P060019S033

Device: THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S033
Product code: LPB
Decision date: 2016-04-29
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.

Current openFDA PMA Record#

Device: THERAPY COOL PATH ABLATION CATHETER, THERAPY COOL PATH SP ABLATION CATHETE, SAFIRE BLU ABLATION CATHETER, SAFIRE BLU SP
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S033
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2016-04-29
Decision code: APPR
Date received: 2015-08-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at St. Jude Medical, 2305 Walnut Street, Roseville, Minnesota, 55113, for rework/relabeling of 12 class III devices.