PMA P860003S036

Device
UVAR PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S036
Product code
LNR
Decision date
2000-11-22
Classification
System, Photopheresis, Extracorporeal
Generic name
System, photopheresis, extracorporeal
Approval order statement
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT HARMAC MEDICAL PRODUCTS, CHEEKTOWAGA, NEW YORK.

Current openFDA PMA Record#

Device
UVAR PHOTOPHERESIS SYSTEM
Applicant
Therakos Development Limited
PMA number
P860003
Supplement
S036
Product code
LNR
Generic name
System, photopheresis, extracorporeal
Decision date
2000-11-22
Decision code
APPR
Date received
2000-05-25
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING FACILITY LOCATED AT HARMAC MEDICAL PRODUCTS, CHEEKTOWAGA, NEW YORK.