PMA P020047S069
- Device
- MULTI-LINK Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S069
- Product code
- MAF
- Decision date
- 2018-07-10
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Change the product bioburden sampling plan for coronary stent systems.
Current openFDA PMA Record#
- Device
- MULTI-LINK Vision/ MULTI-LINK Mini Vision Coronary Stent System, MULTI-LINK 8/ 8 SV/ 8 LL Coronary Stent System
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S069
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2018-07-10
- Decision code
- OK30
- Date received
- 2018-06-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change the product bioburden sampling plan for coronary stent systems.