PMA P810046S217
- Device
- RX VOYAGER CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S217
- Product code
- LOX
- Decision date
- 2005-11-22
- Classification
- Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERY, IRELAND.
Current openFDA PMA Record#
- Device
- RX VOYAGER CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S217
- Product code
- LOX
- Generic name
- Catheters, transluminal coronary angioplasty, percutaneous
- Decision date
- 2005-11-22
- Decision code
- APPR
- Date received
- 2004-11-01
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT GUIDANT IRELAND, TIPPERY, IRELAND.