PMA P020047S056
- Device
- VISION RX, MINI VISION RX,MULTILINK 8 CORONARY STENT SYSTEM(CSS)
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S056
- Product code
- MAF
- Decision date
- 2013-11-14
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE DEVICES.
Current openFDA PMA Record#
- Device
- VISION RX, MINI VISION RX,MULTILINK 8 CORONARY STENT SYSTEM(CSS)
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S056
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2013-11-14
- Decision code
- OK30
- Date received
- 2013-10-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF AN ALTERNATESUPPLIER FOR THE ADAPTION CUP COMPONENTS USED TO MANUFACTURE THE DEVICES.