PMA P900033S073

Device
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S073
Product code
MGR
Decision date
2018-09-12
Classification
Dressing, Wound And Burn, Interactive
Generic name
Dressing, wound and burn, interactive
Approval order statement
Revision to the allowable presterile shipping temperature range.

Current openFDA PMA Record#

Device
Integra Dermal Regeneration Template and Integra Meshed Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S073
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2018-09-12
Decision code
OK30
Date received
2018-08-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Revision to the allowable presterile shipping temperature range.