|
Trade Name | WINGSPAN STENT SYSTEM WITH GATEWAY PTA BALLOON CATHETER |
Classification Name | intracranial neurovascular stent |
Generic Name | intracranial neurovascular stent |
Applicant |
STRYKER CORP. |
47900 bayside parkway |
fremont, CA 94538 |
|
HDE Number | H050001 |
Supplement Number | S074 |
Date Received | 11/25/2015 |
Decision Date | 12/24/2015 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | 30-day notice |
Supplement Reason | process change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Replacement of the existing gateway® pta balloon catheter header bag sealer (pac impulse heat sealers) with the sencorp 12 inch sealers at boston scientific¿s maple grove, minnesota facility where the gateway® pta balloon catheter is manufactured. |