PMA P040014S035
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S035
- Product code
- LPB
- Decision date
- 2019-01-10
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Approval for updates to the warnings section of the Instructions for Use for Ampere Generator and its accessories.
Current openFDA PMA Record#
- Device
- Therapy Ablation Catheters
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S035
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2019-01-10
- Decision code
- APPR
- Date received
- 2018-12-12
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for updates to the warnings section of the Instructions for Use for Ampere Generator and its accessories.