PMA P040014S049
- Device
- Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19-
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S049
- Product code
- LPB
- Decision date
- 2024-10-15
- Classification
- Cardiovascular
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- a change to the bioburden alert and action limits used at the Irvine, California manufacturing facility
Current openFDA PMA Record#
- Device
- Therapy™ Ablation Catheter (4mm and 8mm), Cables 16- 17- 18- & 19-
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S049
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2024-10-15
- Decision code
- OK30
- Date received
- 2024-09-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the bioburden alert and action limits used at the Irvine, California manufacturing facility