PMA P810046S229
- Device
- POWERSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S229
- Product code
- MAF
- Decision date
- 2009-04-24
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- ADDITION OF VISUAL INSPECTION OF THE DISTAL SHAFT AND THE ADDITION OF A VERIFICATION OF IN-PROCESS MEASURING EQUIPMENT.
Current openFDA PMA Record#
- Device
- POWERSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S229
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2009-04-24
- Decision code
- OK30
- Date received
- 2009-04-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF VISUAL INSPECTION OF THE DISTAL SHAFT AND THE ADDITION OF A VERIFICATION OF IN-PROCESS MEASURING EQUIPMENT.