PMA P900033S112

Device
Integra® Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S112
Product code
MGR
Decision date
2024-06-03
Classification
General, Plastic Surgery
Generic name
Dressing, wound and burn, interactive
Approval order statement
Approval to extend the shelf-life from 24 months to 36 months

Current openFDA PMA Record#

Device
Integra® Dermal Regeneration Template
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S112
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2024-06-03
Decision code
APPR
Date received
2024-02-07
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to extend the shelf-life from 24 months to 36 months