PMA P860019S242
- Device
- APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S242
- Product code
- LOX
- Decision date
- 2009-12-04
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- VAPPROVAL FOR A CHANGE IN MATERIAL OF THE MARKERBAND TO A PLATINUM/ IRIDIUM ALLOY.
Current openFDA PMA Record#
- Device
- APEX MONORAIL & OTW PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S242
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2009-12-04
- Decision code
- APPR
- Date received
- 2009-10-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- VAPPROVAL FOR A CHANGE IN MATERIAL OF THE MARKERBAND TO A PLATINUM/ IRIDIUM ALLOY.