PMA P170024S017
- Device
- Surpass Elite Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S017
- Product code
- OUT
- Decision date
- 2024-06-26
- Classification
- Neurology
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- an update to the manufacturing equipment for the stent loading process for the Surpass Elite Flow Diverter System
Current openFDA PMA Record#
- Device
- Surpass Elite Flow Diverter System
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S017
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2024-06-26
- Decision code
- OK30
- Date received
- 2024-05-31
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an update to the manufacturing equipment for the stent loading process for the Surpass Elite Flow Diverter System