PMA P950005S060

Device: EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S060
Product code: LPB
Decision date: 2016-04-25
Classification: Cardiac Ablation Percutaneous Catheter
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.

Current openFDA PMA Record#

Device: EZ Steer DS Bi-Directional Catheter,EZ Steer Bi-Directional CatheterABLATION, Celsius Flutter Bi-Directional Catheter
Applicant: Biosense Webster, Inc.
PMA number: P950005
Supplement: S060
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2016-04-25
Decision code: OK30
Date received: 2016-03-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of a new pouch sealer to be used in the approved facility to seal the primary pouch for the catheter product codes.