- Device
- BIOSENSE WEBSTER CABLES, CELSIUS CATHETER, CELSIUS RMT CATHETER, CLESIUS FLTR, DEFLECTABLE DISGNOSTIC/ABLATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S051
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- 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.