Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAlair Bronchial Thermoplasty System
Generic NameBronchial thermoplasty system
ApplicantBoston Scientific Corp.
888 ROSS DRIVE
SUITE 100
SUNNYVALE, CA 94089
PMA NumberP080032
Supplement NumberS020
Date Received10/28/2021
Decision Date11/26/2021
Product Code OOY 
Advisory Committee Anesthesiology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Rotablator Rotational Angioplasty System, ROTAPRO Rotational Atherectomy System and the Alair Bronchial Thermoplasty System is approved for the addition of automated ultrasonic cleaning equipment with forced air dryer at the supplier for components used in the Rotalink and ROTAPRO Advancers and Alair Catheter.
-
-