PMA P060019S053

Device: Therapy Cool Path
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S053
Product code: OAD
Decision date: 2021-05-18
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Approval order statement: Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.

Current openFDA PMA Record#

Device: Therapy Cool Path
Applicant: Irvine Biomedical, Inc.
PMA number: P060019
Supplement: S053
Product code: OAD
Generic name: catheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Decision date: 2021-05-18
Decision code: OK30
Date received: 2021-04-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Changes to a resin as a result of transferring resin manufacturing from the current supplier manufacturing site in LaPorte, TX to a new supplier manufacturing site in Avon, OH.