FDA.reportPublic FDA data

PMA P170027S005

Device
TherOx Downstream System
Applicant
Zoll Circulation, Inc.
PMA number
P170027
Supplement
S005
Product code
MWG
Decision date
2021-06-01
Generic name
System, oxygen, aqueous
Approval order statement
Approval for a manufacturing site located at ZOLL Circulation Facility (2000 Ringwood Ave, San Jose, CA, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the TherOx® DownStream® System Console only.

Current openFDA PMA Record#

Device
TherOx Downstream System
Applicant
Zoll Circulation, Inc.
PMA number
P170027
Supplement
S005
Product code
MWG
Generic name
System, oxygen, aqueous
Decision date
2021-06-01
Decision code
APPR
Date received
2021-03-23
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 ZOLL Circulation Facility (2000 Ringwood Ave, San Jose, CA, 95131) for the final assembly, testing, final acceptance, and pack-out activities of the TherOx® DownStream® System Console only.