PMA P240009S005

Device: Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection – (Neuroguard I
Applicant: Contego Medical, Inc.
PMA number: P240009
Supplement: S005
Product code: NIM
Decision date: 2025-09-19
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: to a add new minimum sterilization load for the current chamber and add a new sterilization chamber at the contract sterilizer

Current openFDA PMA Record#

Device: Neuroguard IEP® 3-in-1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection – (Neuroguard I
Applicant: Contego Medical, Inc.
PMA number: P240009
Supplement: S005
Product code: NIM
Generic name: Stent, carotid
Decision date: 2025-09-19
Decision code: OK30
Date received: 2025-08-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: to a add new minimum sterilization load for the current chamber and add a new sterilization chamber at the contract sterilizer