PMA P950027S014

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S014
Product code: MOZ
Decision date: 2013-09-26
Classification: Acid, Hyaluronic, Intraarticular
Generic name: Acid, hyaluronic, intraarticular
Approval order statement: APPROVAL FOR A NEW INJECTION SYRINGE (DENOTED AS ¿EZ-FILL SYRINGE¿) FOR HYALGAN® THAT INCORPORATES A TAMPER-EVIDENT CLOSURE SYSTEM CONSISTING OF A SEAL, A TIP CAP, AND A LUER LOCK.

Current openFDA PMA Record#

Device: HYALGAN
Applicant: Fidia Farmaceutici S.P.A.
PMA number: P950027
Supplement: S014
Product code: MOZ
Generic name: Acid, hyaluronic, intraarticular
Decision date: 2013-09-26
Decision code: APPR
Date received: 2013-08-29
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A NEW INJECTION SYRINGE (DENOTED AS ¿EZ-FILL SYRINGE¿) FOR HYALGAN® THAT INCORPORATES A TAMPER-EVIDENT CLOSURE SYSTEM CONSISTING OF A SEAL, A TIP CAP, AND A LUER LOCK.