PMA P840062S077

Device
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S077
Product code
LPG
Decision date
2020-11-18
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S077
Product code
LPG
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
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.