Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | CAROTID WALLSTENT MONORAIL |
Generic Name | STENT, CAROTID |
Applicant | Boston Scientific Corp. Three Scimed Place Maple Grove, MN 55311-1566 |
PMA Number | P050019 |
Supplement Number | S016 |
Date Received | 06/19/2013 |
Decision Date | 07/18/2013 |
Product Code |
NIM |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITIONAL VENDOR LOCATION TO SUPPLY MANUFACTURING AIDS AND COMPONENTS USED IN THE MANUFACTURING PROCESS OF THE DEVICES. |
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