- Device
- APEX MONORAIL & APEX OTW PTCA DILATATION CATHETER/MAVERICK2 MONORAIL PTCA CATHETER/MAVERICK OTW PTCA CATHETER/MAVERICK
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S264
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2011-03-31
- Decision code
- APPR
- Date received
- 2010-10-07
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A CHANGE TO THE STERILIZATION EQUIPMENT.