PMA P950032S053

Device
APLIGRAF
Applicant
Organogenesis, Inc.
PMA number
P950032
Supplement
S053
Product code
MGR
Decision date
2009-09-03
Generic name
Dressing, wound and burn, interactive
Approval order statement
ADDITION OF AN ALTERNATE SUPPLIER INTENDED TO PROVIDE CONSISTENT SUPPLY OF MATERIALS TO PRODUCTION ASSEMBLIES.

Current openFDA PMA Record#

Device
APLIGRAF
Applicant
Organogenesis, Inc.
PMA number
P950032
Supplement
S053
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2009-09-03
Decision code
OK30
Date received
2009-08-04
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ALTERNATE SUPPLIER INTENDED TO PROVIDE CONSISTENT SUPPLY OF MATERIALS TO PRODUCTION ASSEMBLIES.