PMA P040014S029
- Device
- IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S029
- Product code
- LPB
- Decision date
- 2016-02-29
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- Acceptance of an automated process for Ampere Generator region configuration.
Current openFDA PMA Record#
- Device
- IBI THERAPY CARDIAC ABLATION SYSTEM ERS/ 1500T RF GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S029
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2016-02-29
- Decision code
- OK30
- Date received
- 2016-02-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Acceptance of an automated process for Ampere Generator region configuration.