PMA P080032S003

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S003
Product code
OOY
Decision date
2010-09-30
Classification
Bronchial Thermoplasty System
Generic name
Bronchial thermoplasty system
Approval order statement
ADDITION OF A NEW TEST METHOD FOR IMPEDANCE MEASUREMENT ACCURACY.

Current openFDA PMA Record#

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S003
Product code
OOY
Generic name
Bronchial thermoplasty system
Decision date
2010-09-30
Decision code
OK30
Date received
2010-08-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF A NEW TEST METHOD FOR IMPEDANCE MEASUREMENT ACCURACY.