FDA.reportPublic FDA data

PMA P840062S078

Device
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S078
Product code
LPG
Decision date
2021-01-19
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement
Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.

Current openFDA PMA Record#

Device
CollaCote, CollaTape, CollaPlug, Absorbable Collagen Wound Dressing for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S078
Product code
LPG
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date
2021-01-19
Decision code
OK30
Date received
2020-12-23
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Split of an existing Compressed Air Point of Use to support additional packaging capacities at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.