PMA P000036S006

Device
DERMAGRAFT
Applicant
Shire Regenerative Medicine
PMA number
P000036
Supplement
S006
Product code
MGR
Decision date
2008-12-03
Generic name
Dressing, wound and burn, interactive
Approval order statement
CHANGES TO AN ACCEPTANCE TEST METHOD FOR DERMAGRAFT.

Current openFDA PMA Record#

Device
DERMAGRAFT
Applicant
Shire Regenerative Medicine
PMA number
P000036
Supplement
S006
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2008-12-03
Decision code
OK30
Date received
2008-10-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGES TO AN ACCEPTANCE TEST METHOD FOR DERMAGRAFT.