PMA P810046S228
- Device
- VOYAGER RX CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S228
- Product code
- MAF
- Decision date
- 2009-04-06
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL TO RE-ESTABLISH THE TEMECULA, CALIFORNIA MANUFACTURING SITE FOR THE DEVICE.
Current openFDA PMA Record#
- Device
- VOYAGER RX CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S228
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2009-04-06
- Decision code
- APPR
- Date received
- 2009-03-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO RE-ESTABLISH THE TEMECULA, CALIFORNIA MANUFACTURING SITE FOR THE DEVICE.