GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM
FDA premarket approval P000052/S005 · decided 2002-08-22
Approval details
- PMA number
- P000052
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- GALILEO/INTRAVASCULAR RADIOTHERPY SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Guidant Corp.
- Date received
- 2002-02-21
- Decision date
- 2002-08-22
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR HARDWARE AND SOFTWARE CHANGES FOR THE GALILEO SOURCE DELIVERY UNIT, I.E., AN ALTERNATE PRIMARY CIRCUIT BOARD (AMPRO BOARD), LCD DISPLAY AND ASSOCIATED SOFTWARE. THESE CHANGES ARE APPLICABLE TO THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM, WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, THE 27 MM 32P SOURCE WIRE AND THE 27 MM GALILEO CENTERING CATHETER.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| FLEX 10 MIS ABLATION PROBE, MODEL FLX10MI-05 (K061865) | Guidant Corp. | 2006-07-27 |
| HI-TORQUE WHISPER VIEW GUIDE WIRE (K061453) | Guidant Corp. | 2006-06-22 |
| RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM (K042908) | Guidant Corp. | 2004-11-12 |
| ACCUNET EMBOLIC PROTECTION SYSTEM, RX ACCUNET EMBOLIC PROTECTION SYSTEM (K042218) | Guidant Corp. | 2004-08-31 |
| OMNILINK .018 BILIARY STENT SYSTEM (K033834) | Guidant Corp. | 2004-01-02 |
| ABSOLUTE .035 SELF-EXPANDING BILIARY STENT SYSTEM (K033393) | Guidant Corp. | 2003-11-10 |
| HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING (K031678) | Guidant Corp. | 2003-08-26 |
| RAPIDO CUT-AWAY CUTTER (K031459) | Guidant Corp. | 2003-07-23 |