FDA.reportPublic FDA data

PMA P100010S105

Device
Artic Front Advance Pro Cardiac Cryoablation Catheter
Applicant
Medtronic Cryocath, LP
PMA number
P100010
Supplement
S105
Product code
OAE
Decision date
2020-06-18
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Approval order statement
Add an alternate supplier, Medtronic Puerto Rico Operations Co., Villalba, for the manufacture of the Arctic Front Advance Pro Guidewire Lumen (GWL) subassembly.

Current openFDA PMA Record#

Device
Artic Front Advance Pro Cardiac Cryoablation Catheter
Applicant
Medtronic Cryocath, LP
PMA number
P100010
Supplement
S105
Product code
OAE
Generic name
Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation
Decision date
2020-06-18
Decision code
OK30
Date received
2020-05-20
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Add an alternate supplier, Medtronic Puerto Rico Operations Co., Villalba, for the manufacture of the Arctic Front Advance Pro Guidewire Lumen (GWL) subassembly.