THE CLOSER AK 6 FR. SMC DEVICE
FDA premarket approval P960043/S039 · decided 2002-05-21
Approval details
- PMA number
- P960043
- Supplement
- S039
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE CLOSER AK 6 FR. SMC DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2002-04-17
- Decision date
- 2002-05-21
- Days to decision
- 34 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR MANUFACTURING AND MATERIAL DESIGN CHANGES, I.E., CHANGING TO A PRESS-FIT HANDLE, TO A GREEN AND WHITE SUTURE, TO AN INTERNAL SUTURE STORAGE, CHANGING THE THUMB CAP/PLUNGER ATTACHMENT BACK TO WHAT WAS PREVIOUSLY APPROVED IN P960043/S036, AND A CHANGE IN THE O-RING MATERIAL. IN ADDITION, THE LABELING IS BEING MODIFIED TO INCLUDE OTHER HEALTHCARE PROFESSIONALS IN THE PRECAUTION ON THE LIMITATION OF USE TO PHYSICIANS WHO HAVE BEEN TRAINED IN THE USE OF THIS DEVICE. THE DEVICE, AS MODIFI
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510(k) clearances by this applicant
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|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
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| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |