PMA P900033S100

Device: Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S100
Product code: MGR
Decision date: 2022-05-20
Generic name: Dressing, wound and burn, interactive
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: Integra® Dermal Regeneration Template and Integra® Meshed Dermal Regeneration Template
Applicant: Integra Lifesciences Corp.
PMA number: P900033
Supplement: S100
Product code: MGR
Generic name: Dressing, wound and burn, interactive
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.