PMA P170024S001
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S001
- Product code
- OUT
- Decision date
- 2018-10-05
- Classification
- Intracranial Aneurysm Flow Diverter
- Generic name
- Intracranial aneurysm flow diverter
- Approval order statement
- Reduction of the frequency of in-process inspection for the pouch sealing process to once daily.
Current openFDA PMA Record#
- Device
- Surpass Streamline Flow Diverter
- Applicant
- Stryker Neurovascular
- PMA number
- P170024
- Supplement
- S001
- Product code
- OUT
- Generic name
- Intracranial aneurysm flow diverter
- Decision date
- 2018-10-05
- Decision code
- OK30
- Date received
- 2018-09-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Reduction of the frequency of in-process inspection for the pouch sealing process to once daily.