PMA P840062S085

Device: CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S085
Product code: LPG
Decision date: 2022-05-20
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Approval order statement: Replacement of the current two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.

Current openFDA PMA Record#

Device: CollaCote™, CollaTape®, and CollaPlug® Absorbable Collagen Wound Dressings for Dental Surgery
Applicant: Integra Lifesciences Corp.
PMA number: P840062
Supplement: S085
Product code: LPG
Generic name: MATERIAL, DRESSING, SURGICAL, POLYLACTIC ACID
Decision date: 2022-05-20
Decision code: OK30
Date received: 2022-04-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the current two (2) modules of the water purification (RODEI) system with four (4) like-in-kind modules from the same manufacturer to increase purified water capacity at the Integra NeuroSciences manufacturing facility located at Road 402 North, Km 1.2 Añasco, PR 00610.