PMA P010068S040
- Device
- BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S040
- Product code
- OAD
- Decision date
- 2015-12-17
- Classification
- Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.
Current openFDA PMA Record#
- Device
- BIOSENSE WEBSTER CABLES, CELSIUS DS CATHETER, CELSIUS FLTR, EZ STEER NAV DS CATH, NAVISTAR DS CATH, NAVISTAR RMT DS CATH
- Applicant
- Biosense Webster, Inc.
- PMA number
- P010068
- Supplement
- S040
- Product code
- OAD
- Generic name
- catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
- Decision date
- 2015-12-17
- Decision code
- APPR
- Date received
- 2014-07-02
- 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 STERIGENICS, IN LOS ANGELES, CALIFORNIA AS AN ALTERNATE STERILIZATION SITE.