PMA P040014S034
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S034
- Product code
- LPB
- Decision date
- 2018-03-06
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Alternative Electrical Safety Test for the Ampere Generator, Ampere Remote Control and TactiSys Quartz Equipment.
Current openFDA PMA Record#
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S034
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2018-03-06
- Decision code
- OK30
- Date received
- 2018-02-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternative Electrical Safety Test for the Ampere Generator, Ampere Remote Control and TactiSys Quartz Equipment.