FDA.reportPublic FDA data

PMA P840062S087

Device
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S087
Product code
LPG
Decision date
2023-02-23
Classification
Dental
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressings
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S087
Product code
LPG
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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.