PMA P240009S007

Device: Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection
Applicant: Contego Medical, Inc.
PMA number: P240009
Supplement: S007
Product code: NIM
Decision date: 2026-01-28
Classification: Cardiovascular
Generic name: Stent, carotid
Approval order statement: removal of destructive testing at product release, updated in-process monitoring, and the addition of a pneumatic hypotube crimper for wire attachment

Current openFDA PMA Record#

Device: Neuroguard IEP® 3-in-1 Carotid Stent and Post- Dilatation Balloon System with Integrated Embolic Protection
Applicant: Contego Medical, Inc.
PMA number: P240009
Supplement: S007
Product code: NIM
Generic name: Stent, carotid
Decision date: 2026-01-28
Decision code: APPR
Date received: 2025-12-18
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: removal of destructive testing at product release, updated in-process monitoring, and the addition of a pneumatic hypotube crimper for wire attachment