PMA P060019S034
- Device
- THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S034
- Product code
- LPB
- Decision date
- 2015-10-21
- Classification
- Cardiac Ablation Percutaneous Catheter
- Generic name
- Cardiac ablation percutaneous catheter
- Approval order statement
- TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- THERAPY COOL PATH, SAFIRE BLU, SAFIRE BLU SP, AND THERAPY COOL PATH SP ABLATION CATHETERS
- Applicant
- Irvine Biomedical, Inc.
- PMA number
- P060019
- Supplement
- S034
- Product code
- LPB
- Generic name
- Cardiac ablation percutaneous catheter
- Decision date
- 2015-10-21
- Decision code
- OK30
- Date received
- 2015-09-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO REMOVE A REDUNDANT RUN-IN TEST FOR THE AMPERE SYSTEM FROM THE MANUFACTURING PROCESS.