PMA P990071S020
- Device
- STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S020
- Product code
- LPB
- Decision date
- 2012-11-20
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR SOFTWARE AND HARDWARE MODIFICATIONS IMPLEMENTED TO MAKE THE DEVICE COMPLIANT TO IEC 60601-1 3RD EDITION.
Current openFDA PMA Record#
- Device
- STOCKERT 70 RADIOFREQUENCY GENERATOR FOR CARDIAC ABLATION
- Applicant
- Biosense Webster, Inc.
- PMA number
- P990071
- Supplement
- S020
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2012-11-20
- Decision code
- APPR
- Date received
- 2012-08-17
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE AND HARDWARE MODIFICATIONS IMPLEMENTED TO MAKE THE DEVICE COMPLIANT TO IEC 60601-1 3RD EDITION.