PMA P810046S222
- Device
- VOYAGER OTW CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S222
- Product code
- MAF
- Decision date
- 2007-09-27
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR AN ADDITION OF A LUBRICIOUS COATING TO THE INNER LUMEN OF THE CATHETER.
Current openFDA PMA Record#
- Device
- VOYAGER OTW CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S222
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2007-09-27
- Decision code
- APPR
- Date received
- 2007-06-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ADDITION OF A LUBRICIOUS COATING TO THE INNER LUMEN OF THE CATHETER.