THE ORACLE MEGASONICS FIVE-64 PTCA CATHER
FDA premarket approval P910031/S019 · decided 1998-12-11
Approval details
- PMA number
- P910031
- Supplement
- S019
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THE ORACLE MEGASONICS FIVE-64 PTCA CATHER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 1998-06-15
- Decision date
- 1998-12-11
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- Approval for modifications to the Endosonics Oracle MegaSonics Five-64(TM) PTCA Catheter.
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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 |