PMA P040014S002
- Device
- IBI THERAPY ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S002
- Product code
- LPB
- Decision date
- 2005-12-08
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- CHANGE TO THE TUBE FUSING PROCESS AND A CHANGE IN THE ADHESIVE USED IN THE WELD JOINT PROCESS.
Current openFDA PMA Record#
- Device
- IBI THERAPY ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P040014
- Supplement
- S002
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2005-12-08
- Decision code
- OK30
- Date received
- 2005-11-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE TUBE FUSING PROCESS AND A CHANGE IN THE ADHESIVE USED IN THE WELD JOINT PROCESS.