PMA P810046S207
- Device
- HIGHSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S207
- Product code
- LOX
- Decision date
- 2001-05-24
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- MANUFACTURING CHANGE TO MODIFY THE SIDEARM ASSEMBLY AND INSPECTION PROCESS.
Current openFDA PMA Record#
- Device
- HIGHSAIL CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S207
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2001-05-24
- Decision code
- OK30
- Date received
- 2001-05-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING CHANGE TO MODIFY THE SIDEARM ASSEMBLY AND INSPECTION PROCESS.