- Device
- CATHSCANNER ORACLE MICRO PTCA CATHETER FACT BALLOON CORONARY DILATION CATHETER
- Applicant
- Abbott Vascular Devices
- PMA number
- P910031
- Supplement
- S006
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 1996-01-30
- Decision code
- APPR
- Date received
- 1995-11-03
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING SITE:13900 ALTON PARKWAY, SUITE 122, IRVINE, CALIFORNIA, 92718 FOR THE FACT BALLOON CORONARY DILATATION CATHETER