|
Device | ALAIR BRONCHIAL THERMOPLASTY RADIOFREQUENCY CONTROLLER |
Generic Name | Bronchial thermoplasty system |
Applicant | Boston Scientific Corp. 888 ROSS DRIVE SUITE 100 SUNNYVALE, CA 94089 |
PMA Number | P080032 |
Supplement Number | S015 |
Date Received | 03/14/2014 |
Decision Date | 06/17/2014 |
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 STELLARTECH RESEARCH CORPORATION, IN MILPITAS, CALIFORNIA. |
Post-Approval Study | Show Report Schedule and Study Progress |