PMA P040036S047
- Device
- THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S047
- Product code
- LPB
- Decision date
- 2014-11-19
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR MINOR LABELING CHANGES.
Current openFDA PMA Record#
- Device
- THERMOCOOL SMARTTOUCH BI-DIRECTIONAL NAVIGATION CATHETER AND THERMOCOOL SMARTTOUCH UNI-DIRECTIONAL NAVIGATION CATHETER
- Applicant
- Biosense Webster, Inc.
- PMA number
- P040036
- Supplement
- S047
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-11-19
- Decision code
- APPR
- Date received
- 2014-10-30
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MINOR LABELING CHANGES.