PMA P810046S224
- Device
- VOYAGER OTW CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S224
- Product code
- MAF
- Decision date
- 2007-09-19
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- MODIFICATION OF THE MANUFACTURING TOOLS AND IN-PROCESS PARAMETERS USED DURING OUTER MEMBRANE NECKING AND PROXIMAL BALLOON SEALING.
Current openFDA PMA Record#
- Device
- VOYAGER OTW CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S224
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2007-09-19
- Decision code
- OK30
- Date received
- 2007-08-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MODIFICATION OF THE MANUFACTURING TOOLS AND IN-PROCESS PARAMETERS USED DURING OUTER MEMBRANE NECKING AND PROXIMAL BALLOON SEALING.