PMA P810046S237
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S237
- Product code
- LOX
- Decision date
- 2010-06-01
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A CHANGE IN THE IN-PROCESS EXTRUDED BALLOON TUBING OUTER DIAMETER.
Current openFDA PMA Record#
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S237
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2010-06-01
- Decision code
- APPR
- Date received
- 2010-04-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A CHANGE IN THE IN-PROCESS EXTRUDED BALLOON TUBING OUTER DIAMETER.