FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
FDA premarket approval P050043/S005 · decided 2011-07-11
Approval details
- PMA number
- P050043
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- FEMORAL INTRODUCER SHEATH & HEMOSTASIS (FISH) DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Morris Innovative Research, Inc.
- Date received
- 2011-05-12
- Decision date
- 2011-07-11
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Bloomington, IN
- Statement
- APPROVAL FOR: ADDING A CUFF STABILIZER SHEATH, MODIFYING THE SUTURE INDICATOR KNOTS AND UPDATING LABELING. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME FISH- SP ADVANCED COMPRESSION DEVICE AND IS INDICATED FOR "...FOR HEMOSTATIC CLOSURE OF FEMORAL ARTERY ACCESS SITES. THE SYSTEM IS INDICATED FOR USE IN REDUCING TIME TO HEMOSTASIS AND TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC PROCEDURES USING 5, 6, 7 OR 8 FRENCH PROCEDURAL SHEATHS."
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.