PMA P990037S028

Device: DUETT PRO SEALING DEVICE, MODEL 1010
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S028
Product code: MGB
Decision date: 2008-12-17
Classification: Device, Hemostasis, Vascular
Generic name: Device, hemostasis, vascular
Approval order statement: APPROVAL TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS.

Current openFDA PMA Record#

Device: DUETT PRO SEALING DEVICE, MODEL 1010
Applicant: Vascular Solutions, Inc.
PMA number: P990037
Supplement: S028
Product code: MGB
Generic name: Device, hemostasis, vascular
Decision date: 2008-12-17
Decision code: APPR
Date received: 2008-10-21
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL TO EXTENT THE SHELF LIFE OF THE SODIUM PHOSPHATE PROCOAGULANT DILUENT, USED ONLY IN THE DUET PRO SEALING DEVICE, MODEL 1010, FROM 2 YEARS TO 5 YEARS.