PMA P080032S013

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S013
Product code
OOY
Decision date
2013-06-03
Classification
Bronchial Thermoplasty System
Generic name
Bronchial thermoplasty system
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN QUINCY, MASSACHUSETTS.

Current openFDA PMA Record#

Device
ALAIR BRONCHIAL THERMOPLASTY SYSTEM
Applicant
Boston Scientific Corp
PMA number
P080032
Supplement
S013
Product code
OOY
Generic name
Bronchial thermoplasty system
Decision date
2013-06-03
Decision code
APPR
Date received
2013-03-14
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED AT BOSTON SCIENTIFIC CORPORATION IN QUINCY, MASSACHUSETTS.