PMA P990071S061
- Device
- nGEN™ Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S061
- Product code
- LPB
- Decision date
- 2024-10-30
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- approval for minor design changes to the nGEN™ Pump printed circuit board assembly
Current openFDA PMA Record#
- Device
- nGEN™ Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S061
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-10-30
- Decision code
- APPR
- Date received
- 2024-08-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for minor design changes to the nGEN™ Pump printed circuit board assembly