PMA P100046S015

Device: AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S015
Product code: OCM
Decision date: 2023-03-23
Classification: Cardiovascular
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Approval order statement: Alternative epoxy backfilling process to be used on the overmolded insulators found on the sterile OSL2 and OLL2 handpieces.

Current openFDA PMA Record#

Device: AtriCure Isolator Clamp, AtriCure Long Clamp, AtriCure Synergy Clamp
Applicant: AtriCure, Inc.
PMA number: P100046
Supplement: S015
Product code: OCM
Generic name: Surgical cardiac ablation device, for treatment of atrial fibrillation
Decision date: 2023-03-23
Decision code: OK30
Date received: 2023-02-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Alternative epoxy backfilling process to be used on the overmolded insulators found on the sterile OSL2 and OLL2 handpieces.