PMA P810046S221
- Device
- VOYAGER RX CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S221
- Product code
- MAF
- Decision date
- 2006-12-11
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD, OFFALY, IRELAND.
Current openFDA PMA Record#
- Device
- VOYAGER RX CORONARY DILATATION CATHETER
- Applicant
- Advanced Cardiovascular Systems, Inc.
- PMA number
- P810046
- Supplement
- S221
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2006-12-11
- Decision code
- APPR
- Date received
- 2006-11-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ALTERNATE STERILIZATION SITE LOCATED AT ISOTRON IRELAND, LTD, OFFALY, IRELAND.