- Device
- SIMPSON-ROBERT CORONARY BALLOON DILATATION CATHETERS VOYAGER/VOYAGER NC
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S236
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2010-04-23
- Decision code
- OK30
- Date received
- 2010-03-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REQUESTED A CHANGE IN MANUFACTURING EQUIPMENT USED TO COAT THE STENT DELIVERY SYSTEM AND BALLOON DILATATION CATHETERS.