PMA P020047S055
- Device
- MULTI-LINK 8 CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S055
- Product code
- MAF
- Decision date
- 2013-10-28
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.
Current openFDA PMA Record#
- Device
- MULTI-LINK 8 CORONARY STENT SYSTEM
- Applicant
- Abbott Vascular
- PMA number
- P020047
- Supplement
- S055
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2013-10-28
- Decision code
- OK30
- Date received
- 2013-09-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE TO THE SAMPLING PLAN USED FOR PYROGEN TESTING AT THE TEMECULA, CALIFORNIA, MANUFACTURING FACILITY.