PMA P860019S258
- Device
- BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S258
- Product code
- LOX
- Decision date
- 2010-07-28
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- UPDATE OF SOFTWARE USED WITH A CAMERA FOR INSPECTING THE INNER COMPONENT AT THE APEX DISTAL LOAD MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- BSC APEX MONORAIL & OTW PTCA DILATATION CATHETERS
- Applicant
- Scimed Life Systems, Inc.
- PMA number
- P860019
- Supplement
- S258
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-07-28
- Decision code
- OK30
- Date received
- 2010-06-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPDATE OF SOFTWARE USED WITH A CAMERA FOR INSPECTING THE INNER COMPONENT AT THE APEX DISTAL LOAD MANUFACTURING PROCESS.