PMA P950005S071
- Device
- Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S071
- Product code
- LPB
- Decision date
- 2019-03-08
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Alternate qualified supplier of magnet components.
Current openFDA PMA Record#
- Device
- Celsius RMT Catheter; Navistar RMT Thermocool Catheter; Celsius RMT Thermocool Catheter; Navistar RMT Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P950005
- Supplement
- S071
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2019-03-08
- Decision code
- OK30
- Date received
- 2019-02-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate qualified supplier of magnet components.