PMA P990071S023
- Device
- SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S023
- Product code
- LPB
- Decision date
- 2013-07-17
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR A MINOR SOFTWARE UPDATE FOR SMARTABLATE IRRIGATION PUMP FROM VERSION 1.2 TO 1.3.
Current openFDA PMA Record#
- Device
- SMARTABLATE SYSTEM-SMARTABLATE IRRIGATION PUMP KIT
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S023
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2013-07-17
- Decision code
- APPR
- Date received
- 2013-04-29
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MINOR SOFTWARE UPDATE FOR SMARTABLATE IRRIGATION PUMP FROM VERSION 1.2 TO 1.3.