PMA P860019S230
- Device
- MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S230
- Product code
- LOX
- Decision date
- 2009-04-13
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- MAVERICK OTW (OVER-THE-WIRE) AND QUANTUM MAVERICK OTW
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S230
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-04-13
- Decision code
- APPR
- Date received
- 2008-10-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE TO THE BOND LENGTH SPECIFICATION LIMITS FOR THE CATHETER MANUFACTURING PROCESS.