CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
FDA premarket approval P910031/S007 · decided 1996-05-30
Approval details
- PMA number
- P910031
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Applicant
- Abbott Vascular Devices
- Date received
- 1996-01-26
- Decision date
- 1996-05-30
- Days to decision
- 125 days
- Decision code
- APPR
- Product code
- LOX
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Redwood, CA
- Statement
- APPROVAL FOR: 1)AN ADDITIONAL MANUFACTURING SITE (13900 ALTON PARKWAY, SUITE 122, IRVINE, CA, 92718); 2) AN ALTERNATE STERILIZATION SITE (GRIFFITH MICRO SCIENCE, 4900 GIFFORD AVE., LOS ANGELES, CA, 90058); AND 3) AN INCREASE IN THE SHELF LIFE FROM ONE TO TWO YEARS
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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 |