ORACLE MEGASONICS FIVE-64 PTCA CATHETER
FDA premarket approval P910031/S015 · decided 1998-05-01
Approval details
- PMA number
- P910031
- Supplement
- S015
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ORACLE MEGASONICS FIVE-64 PTCA CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 1997-03-28
- Decision date
- 1998-05-01
- Days to decision
- 399 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for Oracle MegaSonics Five-64(TM) PTCA Catheter. The device, as modified, will be marketed under the trade name Oracle MegaSonics Five-64(TM) PTCA Catheter and is indicated for balloon dilatation of stenotic coronary arteries or bypass grafts for the purpose of improving myocardial perfusion. The catheter is further indicated for use following balloon dilatation as an adjunct to conventional angiographic procedures to provide: 1) an image of the vessel lumen and wall structures and 2) d
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM (K052454) | Abbott Vascular Devices | 2005-09-14 |
| MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM (K050501) | Abbott Vascular Devices | 2005-03-14 |