Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | NEUROFORM MICRODELIVERY STENT |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
Stryker Neurovascular |
47900 bayside parkway |
fremont, CA 94538 |
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HDE Number | H020002 |
Supplement Number | S006 |
Date Received | 09/12/2003 |
Decision Date | 12/31/2003 |
Product Code | |
Docket Number | 02M-0409 |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the following changes to the ne~iroform stent: 1) addition of a 30mm length for the 3mam, 3. 5mm, 4mm, and 4. 5mm stents; and 2) ani optional 3-interconniect configuration for the 2. 5mim, 3mm, 3. 5mm-i, 4mm, and 4-5mmu stents. The device, as modified, will remain marketed under the trade name neurofonntm2 microdelivery stenit system. |
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