PMA approvals

CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery

Integra Lifesciences Corp. · MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID · Dental

P840062 S099SupplementOK30
Open FDA's page for this record
PMA number
P840062
Supplement number
S099
Applicant
Integra Lifesciences Corp.
Street 1
311 Enterprise Dr.
City
Planisboro
State
NJ
Zip
08536
Generic name
MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Trade name
CollaCote™, CollaTape®, CollaPlug®, Absorbable Collagen Wound Dressings for Dental Surgery
Product code
LPG
Advisory committee
DE
Advisory committee description
Dental
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited review flag
N
Date received
2026-08-21
Decision date
2026-09-18
Decision code
OK30
Ao statement
installation and qualification of a new Water for Injection (WFI) pretreatment, generation, storage, and distribution system
Harmonized identifiers (openFDA)
Device name
Material, Dressing, Surgical, Polylactic Acid
Medical specialty description
Unknown
Device class
3
Registration number
1121308, 2648988, 3003418325, 1319639, 2650143, 3006540014
FEI number
1121308, 3003418325, 3000204775, 1000138054, 3006540014, 2648209
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.