PMA P030009S080
- Device
- INTEGRITY CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S080
- Product code
- MAF
- Decision date
- 2015-07-09
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.
Current openFDA PMA Record#
- Device
- INTEGRITY CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S080
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2015-07-09
- Decision code
- APPR
- Date received
- 2015-03-20
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR IMPLEMENTING THE SUPPLIER OWNED QUALITY (SOQ) PROGRAM.