|
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 | S014 |
Date Received | 11/05/2013 |
Decision Date | 12/02/2013 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Clinical Trials | NCT00231114
|
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement CHANGE TO THE MANUFACTURING OF A CABLE CONNECTOR, THE ADDITION OF ANINSPECTION STEP AND THE ELIMINATION OF A FINAL ACCEPTANCE ACTIVITY. |
Post-Approval Study | Show Report Schedule and Study Progress |