PMA P170024
- Device
- Surpass Elite™ Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S011
- Product code
- OUT
- Decision date
- 2026-08-28
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Approval for a minor labeling update to a clinical warning and Table 13 of the Instructions for Use.
Current openFDA PMA Record#
- Device
- Surpass Elite™ Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S027
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2026-08-28
- Decision code
- APPR
- Date received
- 2026-07-20
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a minor labeling update to a clinical warning and Table 13 of the Instructions for Use.