PMA P900033S038

Device
INTEGRA DERMAL REGENERATION TEMPLATE
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S038
Product code
MDD
Decision date
2014-10-16
Classification
Device, Dermal Replacement
Generic name
Device, dermal replacement
Approval order statement
USE OF A NEW QUALITY CONTROL TEST METHOD.

Current openFDA PMA Record#

Device
INTEGRA DERMAL REGENERATION TEMPLATE
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S038
Product code
MDD
Generic name
Device, dermal replacement
Decision date
2014-10-16
Decision code
OK30
Date received
2014-09-15
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF A NEW QUALITY CONTROL TEST METHOD.