FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE
FDA premarket approval P050043/S006 · decided 2012-02-28
Approval details
- PMA number
- P050043
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FEMORAL INTRODUCER SHEATH AND HEMOSTASIS DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2012-01-13
- Decision date
- 2012-02-28
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR A NEW VERSION OF THE SUB-INTESTINAL SUBMUCOSA (SIS) MATERIAL (VERSION 2.0).
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