GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
FDA premarket approval P000052/S014 · decided 2002-12-17
Approval details
- PMA number
- P000052
- Supplement
- S014
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Guidant Corp.
- Date received
- 2002-11-21
- Decision date
- 2002-12-17
- Days to decision
- 26 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL TO INCLUDE A WARNING STATEMENT IN THE INSTRUCTIONS FOR USE FOR THE GALILEO III CENTERING CATHETER ADVISING THE USER NOT TO EXCEED A PRESSURE OF 4 ATM, AS POSSIBLE OVEREXPANSION OF THE INFLATION LUMEN COULD RESULT.
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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 |