PMA P860019S241
- Device
- NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S241
- Product code
- LOX
- Decision date
- 2010-04-16
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR: 1) A NEW BALLOON AND MARKERBAND MATERIALS; 2) EXTENSION OF THE PRODUCT MATRIX TO INCLUDE A 6MM LENGTH; 3) AN ALTERNATE BOND FOR MONORAIL MODELS; AND 4) A CHANGE IN THE HYDROPHILIC COATING LENGTH ON OVER-THE-WIRE MODELS.
Current openFDA PMA Record#
- Device
- NC QUANTUM APEX MONORAIL AND OVER-THE-WIRE PTCA CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S241
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-04-16
- Decision code
- APPR
- Date received
- 2009-09-04
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) A NEW BALLOON AND MARKERBAND MATERIALS; 2) EXTENSION OF THE PRODUCT MATRIX TO INCLUDE A 6MM LENGTH; 3) AN ALTERNATE BOND FOR MONORAIL MODELS; AND 4) A CHANGE IN THE HYDROPHILIC COATING LENGTH ON OVER-THE-WIRE MODELS.