PMA P860019S234
- Device
- MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S234
- Product code
- LOX
- Decision date
- 2009-09-18
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR CHANGES TO THE SILICONE MATERIAL.
Current openFDA PMA Record#
- Device
- MAVERICK2 MONORAIL (MR), MAVERICK OVER-THE-WIRE (OTW), QUANTUM MAVERICK MR AND OTW
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S234
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-09-18
- Decision code
- APPR
- Date received
- 2009-04-10
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR CHANGES TO THE SILICONE MATERIAL.