PTCA CATHETERS
FDA premarket approval P860019/S229 · decided 2008-11-04
Approval details
- PMA number
- P860019
- Supplement
- S229
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- PTCA CATHETERS
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Scimed Life Systems, Inc.
- Date received
- 2008-10-08
- Decision date
- 2008-11-04
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- ALTERNATE METHOD FOR FINAL PACKAGING OF THE DEVICE INCLUDING LABEL DESIGN CHANGES UNDER THE BSC MASTER BRAND.
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 |
|---|---|---|
| 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 |