- Device
- CATHSCANNER ORACLE MICRO PTCA CATHETER FACT & ARC BALLOON CORONARY DILATATION CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S007
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-05-30
- Decision code
- APPR
- Date received
- 1996-01-26
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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