PMA P990071S029
- Device
- COOLFLOW IRRIGATION PUMP
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S029
- Product code
- LPB
- Decision date
- 2014-11-19
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR CHANGES TO SOLDER COMPOSITION REQUIRED FOR EU ROHS COMPLIANCE.
Current openFDA PMA Record#
- Device
- COOLFLOW IRRIGATION PUMP
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S029
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2014-11-19
- Decision code
- APPR
- Date received
- 2014-09-10
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR CHANGES TO SOLDER COMPOSITION REQUIRED FOR EU ROHS COMPLIANCE.