PMA P840062S090

Device
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S090
Product code
LPG
Decision date
2023-05-10
Classification
Dental
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement
Qualification of a new purified water tank.

Current openFDA PMA Record#

Device
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Applicant
Integra Lifesciences Corp.
PMA number
P840062
Supplement
S090
Product code
LPG
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date
2023-05-10
Decision code
OK30
Date received
2023-04-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Qualification of a new purified water tank.