VASOSEAL (TM)
FDA premarket approval P920004/S006 · decided 1997-04-15
Approval details
- PMA number
- P920004
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VASOSEAL (TM)
- Generic name
- Device, hemostasis, vascular
- Applicant
- St. Jude Medical, Inc.
- Date received
- 1997-02-25
- Decision date
- 1997-04-15
- Days to decision
- 49 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A CHANGE TO THE INDICATIONS FOR USE TO INCLUDE SUE OF VASOSEAL(R) FOLLOWING STENT IMPLANTATION. THE VASOSEAL(R) VASCULAR HEMOSTASIS DEVICE IS NOW INDICATED FOR USE IN REDUCING TIEM TO HEMOSTASIS AT THE FEMORAL ARTERIAL PUNCTURE SITE AND IN REDUCING TIME TO AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ANGIOGRAPHY, BALLOON ANGIOPLASTY OR STENT PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL(R) VHD IS ALSO INDICATED FOR US
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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 |