PMA P080032S009

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S009
Product code
OOY
Decision date
2012-06-26
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
S009
Product code
OOY
Generic name
Bronchial thermoplasty system
Decision date
2012-06-26
Decision code
APPR
Date received
2012-02-14
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.