PMA P050043S006
- Device
- FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE
- Applicant
- Morris Innovative Research, Inc.
- PMA number
- P050043
- Supplement
- S006
- Product code
- MGB
- Decision date
- 2012-02-28
- Classification
- Device, Hemostasis, Vascular
- Generic name
- Device, hemostasis, vascular
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE SUB-INTESTINAL SUBMUCOSA (SIS) MATERIAL (VERSION 2.0).
Current openFDA PMA Record#
- Device
- FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE
- Applicant
- Morris Innovative Research, Inc.
- PMA number
- P050043
- Supplement
- S006
- Product code
- MGB
- Generic name
- Device, hemostasis, vascular
- Decision date
- 2012-02-28
- Decision code
- APPR
- Date received
- 2012-01-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE SUB-INTESTINAL SUBMUCOSA (SIS) MATERIAL (VERSION 2.0).