GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
FDA premarket approval P000052 · decided 2001-11-02
Approval details
- PMA number
- P000052
- Trade name
- GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
- Generic name
- Intravascular radiation delivery system
- Applicant
- Guidant Corp.
- Date received
- 2000-12-18
- Decision date
- 2001-11-02
- Days to decision
- 319 days
- Decision code
- APWD
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM WHICH CONSISTS OF THE GALILEO SOURCE DELIVERY UNIT, 27 MM GALILEO CENTERING CATHETER, AND 27 MM 32P SOURCE WIRE. THE DEVICE IS INDICATED TO DELIVER BETA RADIATION TO THE SITE OF SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION (PCI) FOR THE TREATMENT OF IN-STENT RESTENOSIS IN NATIVE CORONARY ARTERIES WITH DISCRETE LESIONS <= 47 MM IN REFERENCE VESSEL DIAMETER 2.4 MM TO 3.7 MM.
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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 |