FDA.reportPublic FDA data

PMA P900033S091

Device
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S091
Product code
MGR
Decision date
2020-11-18
Generic name
Dressing, wound and burn, interactive
Approval order statement
Sampling site changes in Routine Environmental Monitoring for Alkaline treatment rooms at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

Current openFDA PMA Record#

Device
Integra Dermal Regeneration Template, Integra Meshed Dermal Regeneration Template and Integra Omnigraft Dermal Regenerat
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S091
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2020-11-18
Decision code
OK30
Date received
2020-10-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Sampling site changes in Routine Environmental Monitoring for Alkaline treatment rooms at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.