PMA P200002S009
- Device
- Cannula with Guide
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S009
- Product code
- OCM
- Decision date
- 2024-08-28
- Classification
- Cardiovascular
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Approval order statement
- an alternate pigment for the Cannula with Guide (CSK-6131)
Current openFDA PMA Record#
- Device
- Cannula with Guide
- Applicant
- AtriCure, Inc.
- PMA number
- P200002
- Supplement
- S009
- Product code
- OCM
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Decision date
- 2024-08-28
- Decision code
- APPR
- Date received
- 2024-05-31
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- an alternate pigment for the Cannula with Guide (CSK-6131)