NC BIG RANGER PTCA CATHETER
FDA premarket approval P860019/S192 · decided 2002-12-17
Approval details
- PMA number
- P860019
- Supplement
- S192
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- NC BIG RANGER PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 2002-11-25
- Decision date
- 2002-12-17
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL TO MODIFY THE LABELING TO EXTEND THE BALLOON COMPLIANCE CHART DIAMETERS TO HUNDREDTHS AND TO ADD A NOTE TO THE DIRECTIONS FOR USE STATING THE RECOMMENDED MINIMUM GUIDE CATHETER LUMEN INNER DIAMETER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SCIMED INFORMER PRESSURE WIRE SYSTEM (K974241) | Scimed Life Systems, Inc. | 1998-11-12 |
| SCIMED 6 FRENCH WISEGUIDE GUIDE CATHETER (K981788) | Scimed Life Systems, Inc. | 1998-08-18 |
| SCIMED QUEST FLOPPY AND MODERATE SUPPORT GUIDE WIRES (K980360) | Scimed Life Systems, Inc. | 1998-04-29 |
| SCIMED 6 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS (K974559) | Scimed Life Systems, Inc. | 1998-02-23 |
| SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER (K974684) | Scimed Life Systems, Inc. | 1998-02-19 |
| LUGE GUIDE WIRE (K973945) | Scimed Life Systems, Inc. | 1998-01-12 |
| SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER (K970823) | Scimed Life Systems, Inc. | 1997-06-03 |
| CHOICE SUPER SUPPORT PTCA GUIDE WIRE, CHOICE PLUS SUPER SUPPORT PTCA GUIDE WIRE, CHOICE EXCHANGE SUPER SUPPORT PTCA GUID (K964551) | Scimed Life Systems, Inc. | 1997-05-21 |