PMA P040014S043
- Device
- Therapy and Therapy Dual-8
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S043
- Product code
- LPB
- Decision date
- 2021-03-24
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Addition of an alternative bacterial endotoxin test method.
Current openFDA PMA Record#
- Device
- Therapy and Therapy Dual-8
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S043
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2021-03-24
- Decision code
- OK30
- Date received
- 2021-02-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of an alternative bacterial endotoxin test method.