GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
FDA premarket approval P000052/S019 · decided 2003-07-24
Approval details
- PMA number
- P000052
- Supplement
- S019
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS
- Generic name
- Intravascular radiation delivery system
- Applicant
- Guidant Corp.
- Date received
- 2003-06-30
- Decision date
- 2003-07-24
- Days to decision
- 24 days
- Decision code
- APPR
- Product code
- MOU
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL OF THE FOLLOWING CHANGES TO THE LABELING: 1) ADDING A WARNING STATEMENT ALERTING USERS TO THE POTENTIAL FOR A RADIATION OVERDOSE IF AN INTERRUPTED TREATMENT IS NOT RESUMED APPROPRIATELY. 2) MODIFYING THE EMERGENCY RESPONSE PROCEDURES TO ASSIST USERS TO RETRACT THE ACTIVE WIRE IN THE MOST EXPEDITIOUS MANNER WHILE MAINTAINING SAFETY OF THE PATIENT AND THE RADIATION PERSONNEL INVOLVED IN CASE OF AN EMERGENCY.
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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 |