PMA P240009S011
- Device
- Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
- Applicant
- Contego Medical, Inc.
- PMA number
- P240009
- Supplement
- S011
- Product code
- NIM
- Decision date
- 2026-05-27
- Classification
- Cardiovascular
- Generic name
- Stent, carotid
- Approval order statement
- a change from a manual to an automated microblasting process for stent manufacturing
Current openFDA PMA Record#
- Device
- Neuroguard IEP® 3-in-1 Carotid Stent, Post-Dilation Balloon System with Integrated Embolic Protection
- Applicant
- Contego Medical, Inc.
- PMA number
- P240009
- Supplement
- S011
- Product code
- NIM
- Generic name
- Stent, carotid
- Decision date
- 2026-05-27
- Decision code
- OK30
- Date received
- 2026-04-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change from a manual to an automated microblasting process for stent manufacturing