FDA.reportPublic FDA data

PMA P170024S002

Device
Surpass Streamline Flow Diverter
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S002
Product code
OUT
Decision date
2018-11-14
Classification
Intracranial Aneurysm Flow Diverter
Generic name
Intracranial aneurysm flow diverter
Approval order statement
Approval for revisions to the Directions for Use (DFU) to include additional precautionary language regarding the use of magnetic resonance angiography (MRA) for patient follow-up to assess intracranial aneurysm occlusion.

Current openFDA PMA Record#

Device
Surpass Streamline Flow Diverter
Applicant
Stryker Neurovascular
PMA number
P170024
Supplement
S002
Product code
OUT
Generic name
Intracranial aneurysm flow diverter
Decision date
2018-11-14
Decision code
APPR
Date received
2018-10-15
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for revisions to the Directions for Use (DFU) to include additional precautionary language regarding the use of magnetic resonance angiography (MRA) for patient follow-up to assess intracranial aneurysm occlusion.