FDA.reportPublic FDA data

PMA P200002S006

Device
EPi-Sense ST RF Cable
Applicant
AtriCure, Inc.
PMA number
P200002
Supplement
S006
Product code
OCM
Decision date
2023-05-25
Classification
Cardiovascular
Generic name
Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement
Expansion of the current manufacturing campus for the CSK-2060 to include an additional building located at 7555B Innovation Way, Mason, OH 45040 and an update to a pouch sealing test method.

Current openFDA PMA Record#

Device
EPi-Sense ST RF Cable
Applicant
AtriCure, Inc.
PMA number
P200002
Supplement
S006
Product code
OCM
Generic name
Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date
2023-05-25
Decision code
OK30
Date received
2023-04-28
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Expansion of the current manufacturing campus for the CSK-2060 to include an additional building located at 7555B Innovation Way, Mason, OH 45040 and an update to a pouch sealing test method.