PMA P020047S059
- Device
- ML8 CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S059
- Product code
- MAF
- Decision date
- 2014-10-09
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO THE PYROGEN TESTING PROCESS.
Current openFDA PMA Record#
- Device
- ML8 CORONARY STENT SYSTEMS
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S059
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-10-09
- Decision code
- OK30
- Date received
- 2014-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE PYROGEN TESTING PROCESS.