|
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 | S004 |
Date Received | 08/13/2010 |
Decision Date | 02/04/2011 |
Product Code |
OOY |
Advisory Committee |
Anesthesiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING GAMMA IRRADIATION AS AN ALTERNATIVE STERILIZATION METHOD, ESTABLISHING EXPIRATION DATING FOR THAT STERILIZATION METHOD, AND ADDING STERIGENICS (HAYWARD, CALIFORNIA) AS A CONTRACT STERILIZER. |