Cannula with Guide
FDA premarket approval P200002/S009 · decided 2024-08-28
Approval details
- PMA number
- P200002
- Supplement
- S009
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Cannula with Guide
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2024-05-31
- Decision date
- 2024-08-28
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- Statement
- an alternate pigment for the Cannula with Guide (CSK-6131)
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