PMA P040014S024
- Device
- THERAPY ABLATION CATHETER
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S024
- Product code
- LPB
- Decision date
- 2015-07-09
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.
Current openFDA PMA Record#
- Device
- THERAPY ABLATION CATHETER
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S024
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2015-07-09
- Decision code
- APPR
- Date received
- 2014-11-07
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR CHANGES IN THE CLEANING AND RE-STERILIZATION INSTRUCTIONS IN THE LABELING FOR CONNECTOR CABLES USED IN CARDIAC ABLATION DEVICES.