X-SITE SUTURE-MEDIATED CLOSURE DEVICE
FDA premarket approval P020035/S002 · decided 2006-03-03
Approval details
- PMA number
- P020035
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- X-SITE SUTURE-MEDIATED CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- St. Jude Medical, Inc.
- Date received
- 2005-11-30
- Decision date
- 2006-03-03
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR VARIOUS LABELING CHANGES AND ERGONOMIC CHANGES TO THE DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME X-SITE SUTURE-MEDIATED CLOSURE DEVICE AND IS INDICATED FOR ??THE PERCUTANEOUS DELIVERY OF SUTURE FOR CLOSING THE COMMON FEMORAL ARTERY ACCESS SITE OF PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL CORONARY CATHETERIZATION PROCEDURES USING SHEATHS LESS THAN OR EQUAL TO 6 FR. THE X-SITE SUTURE-MEDIATED CLOSURE DEVICE IS INTENDED TO REDUCE THE TIME TO H
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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 |