PMA P080032S002

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S002
Product code
OOY
Decision date
2010-07-27
Classification
Bronchial Thermoplasty System
Generic name
Bronchial thermoplasty system
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S002
Product code
OOY
Generic name
Bronchial thermoplasty system
Decision date
2010-07-27
Decision code
APPR
Date received
2010-05-28
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.