PMA P810046S238
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S238
- Product code
- LOX
- Decision date
- 2010-05-13
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- CHANGE IN THE EXTRUSION PROCESS FOR THE TUBING USED TO MANUFACTURE THE VOYAGER® NC CORONARY DILATATION CATHETER¿S 3.50 MM THROUGH 5.00 MM BALLOONS.
Current openFDA PMA Record#
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S238
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-05-13
- Decision code
- OK30
- Date received
- 2010-04-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE IN THE EXTRUSION PROCESS FOR THE TUBING USED TO MANUFACTURE THE VOYAGER® NC CORONARY DILATATION CATHETER¿S 3.50 MM THROUGH 5.00 MM BALLOONS.