FDA.reportPublic FDA data

PMA P900033S105

Device
Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S105
Product code
MGR
Decision date
2023-02-23
Classification
General, Plastic Surgery
Generic name
Dressing, wound and burn, interactive
Approval order statement
Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at the Integra LifeSciences Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ 08536.

Current openFDA PMA Record#

Device
Integra Dermal Regeneration Template - Terminally Sterilized, Integra Meshed Dermal Regeneration Template - Terminally S
Applicant
Integra Lifesciences Corp.
PMA number
P900033
Supplement
S105
Product code
MGR
Generic name
Dressing, wound and burn, interactive
Decision date
2023-02-23
Decision code
OK30
Date received
2023-01-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Replacement of the current stainless-steel AT basket/paddle with a modular polyethylene/stainless steel AT basket to improve ergonomics and reduce wear particles as a result of paddle motion at the Integra LifeSciences Collagen Manufacturing Center located at 105 Morgan Lane, Plainsboro, NJ 08536.