PMA P030047S052

Device: PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
Applicant: Cordis US Corporation
PMA number: P030047
Supplement: S052
Product code: NIM
Decision date: 2025-10-21
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica

Current openFDA PMA Record#

Device: PRECISE® PRO Rx Nitinol Stent System; PRECISE® PRO Transcarotid Stent System
Applicant: Cordis US Corporation
PMA number: P030047
Supplement: S052
Product code: NIM
Generic name: Stent, carotid
Decision date: 2025-10-21
Decision code: OK30
Date received: 2025-09-26
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to transfer post-laser manufacturing processes of the stent component from Confluent in Fremont, California, to Confluent in Costa Rica