|
Device | ALAIR BRONCHIAL THERMOPLASTY SYSTEM |
Generic Name | Bronchial thermoplasty system |
Applicant | Boston Scientific Corp. 888 ROSS DRIVE SUITE 100 SUNNYVALE, CA 94089 |
PMA Number | P080032 |
Supplement Number | S013 |
Date Received | 03/14/2013 |
Decision Date | 06/03/2013 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT00231114
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN QUINCY, MASSACHUSETTS. |
Post-Approval Study | Show Report Schedule and Study Progress |