PMA P040036S101
- Device
- THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S101
- Product code
- LPB
- Decision date
- 2026-09-15
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- an additional supplier for critical components
Current openFDA PMA Record#
- Device
- THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER; THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S101
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2026-09-15
- Decision code
- OK30
- Date received
- 2026-08-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for critical components