PMA P990071S044
- Device
- nGEN Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S044
- Product code
- LPB
- Decision date
- 2020-07-17
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for design, software and labeling changes to the nGEN pump.
Current openFDA PMA Record#
- Device
- nGEN Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S044
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2020-07-17
- Decision code
- APPR
- Date received
- 2020-04-20
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for design, software and labeling changes to the nGEN pump.