- Device
- THERAPY COOL PATH ABLATION CATHETER AND IBI-1500T9 RF ABLATION GENERATOR
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S032
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2016-02-24
- Decision code
- APPR
- Date received
- 2015-05-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for a manufacturing site located at Irvine Biomedical, Inc., in Irvine, California.