PMA P030009S077
- Device
- INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S077
- Product code
- MAF
- Decision date
- 2014-05-02
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- UPGRADE TO THE WIRE FORMING MACHINE THAT IS CURRENTLY USED ON INTEGRITY STENTS.
Current openFDA PMA Record#
- Device
- INTEGRITY CORONARY STENT SYSTEM
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S077
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2014-05-02
- Decision code
- OK30
- Date received
- 2014-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- UPGRADE TO THE WIRE FORMING MACHINE THAT IS CURRENTLY USED ON INTEGRITY STENTS.