PMA P810046S232
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S232
- Product code
- MAF
- Decision date
- 2010-02-04
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.
Current openFDA PMA Record#
- Device
- VOYAGER NC CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S232
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2010-02-04
- Decision code
- APPR
- Date received
- 2009-12-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A LINE EXTENSION FOR A 1.5MM DIAMETER SIZE OF THE VOYAGER NC CORONARY DILATION CATHETER.