PMA P020047S032
- Device
- MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S032
- Product code
- MAF
- Decision date
- 2011-05-19
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL TO REMOVE A REDUNDANT VERIFICATION STEP FOR A SPIRAL MANDREL USED IN THE STENT MANUFACTURING PROCESS.
Current openFDA PMA Record#
- Device
- MULTI-LINK VISION & MULTI-LINK MINI-VISION OTW & RX; ML-8
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S032
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2011-05-19
- Decision code
- APPR
- Date received
- 2011-02-11
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL TO REMOVE A REDUNDANT VERIFICATION STEP FOR A SPIRAL MANDREL USED IN THE STENT MANUFACTURING PROCESS.