PMA P040013S022

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S022
Product code: NPZ
Decision date: 2019-08-19
Classification: Bone Grafting Material, Dental, With Biologic Component
Generic name: Bone grafting material, dental, with biologic component
Approval order statement: Approval to change the supplier who fills the B-TCP cup component of the GEM21S device from A+ Secure Packaging to Alliance Contract Pharma.

Current openFDA PMA Record#

Device: GEM21S Growth Factor Enhanced Matrix
Applicant: Lynch Biologics, LLC
PMA number: P040013
Supplement: S022
Product code: NPZ
Generic name: Bone grafting material, dental, with biologic component
Decision date: 2019-08-19
Decision code: APPR
Date received: 2019-03-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval to change the supplier who fills the B-TCP cup component of the GEM21S device from A+ Secure Packaging to Alliance Contract Pharma.