PMA P930021S016

Device: STRAUMANN EMDOGAIN(R)
Applicant: The Straumann Company
PMA number: P930021
Supplement: S016
Product code: NQA
Decision date: 2017-03-28
Classification: Biologic Material, Dental
Generic name: Biologic material, dental
Approval order statement: Approval for 1) adding an alternate glass syringe supplier (Design Change); 2) adding an alternate tamper-evident luer cap design (Design Change); 3) adding an alternate cavity design of the thermoformed tray; part of the secondary sterile barrier packaging (Design Change); 4) adding an alternate supplier of the Tyvek 1073B lid stock which includes a change in adhesive coating; part of the secondary sterile barrier packaging (Design Change); in addition, addressing the change to Transition Tyvek with this supplement; and 4) changing the configuration, artwork and labeling of the tertiary shelf packaging (Design Change).

Current openFDA PMA Record#

Device: STRAUMANN EMDOGAIN(R)
Applicant: The Straumann Company
PMA number: P930021
Supplement: S016
Product code: NQA
Generic name: Biologic material, dental
Decision date: 2017-03-28
Decision code: APPR
Date received: 2016-04-06
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for 1) adding an alternate glass syringe supplier (Design Change); 2) adding an alternate tamper-evident luer cap design (Design Change); 3) adding an alternate cavity design of the thermoformed tray; part of the secondary sterile barrier packaging (Design Change); 4) adding an alternate supplier of the Tyvek 1073B lid stock which includes a change in adhesive coating; part of the secondary sterile barrier packaging (Design Change); in addition, addressing the change to Transition Tyvek with this supplement; and 4) changing the configuration, artwork and labeling of the tertiary shelf packaging (Design Change).