PMA P900033S062

Device
Integre Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S062
Product code
MGR
Decision date
2017-07-11
Classification
Dressing, Wound And Burn, Interactive
Generic name
Dressing, wound and burn, interactive
Approval order statement
Installation, operation and performance qualification of a cold storage room.

Current openFDA PMA Record#

Device
Integre Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S062
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2017-07-11
Decision code
OK30
Date received
2017-06-12
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Installation, operation and performance qualification of a cold storage room.