PMA P990071S062
- Device
- Theermocool SF NAV Bi-Directional Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S062
- Product code
- LPB
- Decision date
- 2024-11-20
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- an additional supplier for electromagnetic interference (EMI) shield components
Current openFDA PMA Record#
- Device
- Theermocool SF NAV Bi-Directional Catheter
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S062
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-11-20
- Decision code
- OK30
- Date received
- 2024-10-15
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional supplier for electromagnetic interference (EMI) shield components