PMA P990071S064
- Device
- nGEN™ Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S064
- Product code
- LPB
- Decision date
- 2025-01-22
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- to remove a duplicate physical inspection step and to add a vacuum sealing step for the existing moisture bag
Current openFDA PMA Record#
- Device
- nGEN™ Pump
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S064
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2025-01-22
- Decision code
- OK30
- Date received
- 2024-12-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to remove a duplicate physical inspection step and to add a vacuum sealing step for the existing moisture bag