PMA P020047S035
- Device
- VISION & ML8 CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S035
- Product code
- MAF
- Decision date
- 2011-10-04
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS.
Current openFDA PMA Record#
- Device
- VISION & ML8 CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S035
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2011-10-04
- Decision code
- APPR
- Date received
- 2011-05-09
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AUTOMATION OF THE EXISTING BALLOON NECKING PROCESS.