PMA P020045S111

Device: Coaxial Umbilical Cable
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S111
Product code: LPB
Decision date: 2024-11-13
Classification: Cardiovascular
Generic name: Cardiac ablation percutaneous catheter
Approval order statement: approval for the addition of the Centerpiece (Tijuana, Mexico) as an alternate Ethylene Oxide (EO) sterilization vendor for the Manual Retraction Kit (20MRK) and Coaxial Umbilical Cable (203CX and 203CXC)

Current openFDA PMA Record#

Device: Coaxial Umbilical Cable
Applicant: Medtronic Cryocath, LP
PMA number: P020045
Supplement: S111
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2024-11-13
Decision code: APPR
Date received: 2024-09-12
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for the addition of the Centerpiece (Tijuana, Mexico) as an alternate Ethylene Oxide (EO) sterilization vendor for the Manual Retraction Kit (20MRK) and Coaxial Umbilical Cable (203CX and 203CXC)