ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS
FDA premarket approval P970020/S005 · decided 1999-02-18
Approval details
- PMA number
- P970020
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS AND ACS RX MULTI-LINK CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 1998-08-17
- Decision date
- 1999-02-18
- Days to decision
- 185 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- Approval to add the indication for abrupt or threatened abrupt closure to the product labeling for the ACS Multi-Link(TM) (OTW, RX HP(TM), and OTW HP(TM)), ACS Multi-Link RX, ACS Multi-Link (RX and OTW) Duet(TM) Coronary Stent Systems (CSS); and approval for additional stent sizes for the ACS Multi-Link RX (stents with 2.5 mm diameter or 35 mm length) and ACS Multi-Link (RX and OTW) Duet(TM) (stents with 2.5 mm diameter or 38 mm length)CSS. These devices are indicated for use as follows: The ACS
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| 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 |