PMA P100046S001

Device
ATRICURE SYNERGY ABLATION SYSTEM
Applicant
AtriCure, Inc.
PMA number
P100046
Supplement
S001
Product code
OCM
Decision date
2012-08-15
Classification
Surgical Cardiac Ablation Device, For Treatment Of Atrial Fibrillation
Generic name
Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
ATRICURE SYNERGY ABLATION SYSTEM
Applicant
AtriCure, Inc.
PMA number
P100046
Supplement
S001
Product code
OCM
Generic name
Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date
2012-08-15
Decision code
APPR
Date received
2012-02-14
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.