|
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 | S003 |
Date Received | 08/02/2010 |
Decision Date | 09/30/2010 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF A NEW TEST METHOD FOR IMPEDANCE MEASUREMENT ACCURACY. |