EPi-Sense ST RF Cable
FDA premarket approval P200002/S006 · decided 2023-05-25
Approval details
- PMA number
- P200002
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- EPi-Sense ST RF Cable
- Generic name
- Surgical cardiac ablation device, for treatment of atrial fibrillation
- Applicant
- AtriCure, Inc.
- Date received
- 2023-04-28
- Decision date
- 2023-05-25
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OCM
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mason, OH
- 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.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.