VASOSEAL ELITE VHD/ES DEVICE
FDA premarket approval P920004/S018 · decided 2002-08-13
Approval details
- PMA number
- P920004
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VASOSEAL ELITE VHD/ES DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- St. Jude Medical, Inc.
- Date received
- 2002-03-26
- Decision date
- 2002-08-13
- Days to decision
- 140 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE USE OF A SINGLE SPONGE COLLAGEN PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ELITE VHD OR ES DEVICE AND IS INDICATED FOR: "SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOST
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Advisor HD Grid Mapping Catheter, Sensor Enabled (K172393) | St. Jude Medical, Inc. | 2018-04-23 |
| Confirm Rx Insertable Cardiac Monitor (ICM) System (K163407) | St. Jude Medical, Inc. | 2017-09-29 |
| PressureWire X Guidewire (K161171) | St. Jude Medical, Inc. | 2016-08-15 |
| Nanostim Introducer Kit (K161102) | St. Jude Medical, Inc. | 2016-05-19 |
| The Nanostim Introducer Kit (K160716) | St. Jude Medical, Inc. | 2016-04-14 |
| NANOSTIM INTRODUCER KIT (K140793) | St. Jude Medical, Inc. | 2014-12-17 |
| SJM CONFIRM IMPLANTABLE CARDIAC MONITOR (ICM) (K133481) | St. Jude Medical, Inc. | 2014-05-28 |
| ENLIGHTN RENAL GUIDE CATHETER (K131592) | St. Jude Medical, Inc. | 2014-01-31 |