PMA P810046S213
- Device
- ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S213
- Product code
- DYG
- Decision date
- 2002-10-23
- Classification
- Catheter, Flow Directed
- Generic name
- CATHETER, FLOW DIRECTED
- Approval order statement
- CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.
Current openFDA PMA Record#
- Device
- ESPRIT/CROSSAIL/OPENSAIL/POWERSAIL/HIGHSAIL CORONARY DILATION CATHETHERS
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S213
- Product code
- DYG
- Generic name
- CATHETER, FLOW DIRECTED
- Decision date
- 2002-10-23
- Decision code
- OK30
- Date received
- 2002-09-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO A REVISED SAMPLING GROUP AND A PYROGEN SAMPLING PLAN FOR CORONARY DILATATION CATHETERS.