FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
FDA premarket approval P050043/S004 · decided 2011-03-17
Approval details
- PMA number
- P050043
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FEMORAL INTRODUCER SHEATH & HEMOSTASIS DEVICE (FISH)
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2011-01-18
- Decision date
- 2011-03-17
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR: 1) REPLACING THE SEWN TWO-PIECE SMALL INTESTINE SUBMOCOSA (SIS) ASSEMBLY WITH A SINGLE SIS PIECE; 2) DECREASING THE SIS CUFF LENGTH AND RIBBON WIDTH; 3) MODIFYING THE SIS PATCH TO RELEASE WIRE CONNECTION; AND 4) CHANGING THE SHEATH MATERIAL FROM A HIGH DENSITY POLYETHYLENE (HDPE) TO FLUORINATED ETHYLENE PROPYLENE (FEP).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.