PMA P950032S065

Device
APLIGRAF
Applicant
Organogenesis, Inc.
PMA number
P950032
Supplement
S065
Product code
MGR
Decision date
2011-11-22
Classification
Dressing, Wound And Burn, Interactive
Generic name
Dressing, wound and burn, interactive
Approval order statement
IMPLEMENTATION OF AN ALTERNATE VENDOR.

Current openFDA PMA Record#

Device
APLIGRAF
Applicant
Organogenesis, Inc.
PMA number
P950032
Supplement
S065
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2011-11-22
Decision code
OK30
Date received
2011-10-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
IMPLEMENTATION OF AN ALTERNATE VENDOR.