PMA P030009S093
- Device
- Integrity Coronary Stent System
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S093
- Product code
- MAF
- Decision date
- 2017-12-20
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Introduce software for monitoring the Controlled Environment Areas (CEAs) at the Empalme, Mexico manufacturing facility.
Current openFDA PMA Record#
- Device
- Integrity Coronary Stent System
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S093
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-12-20
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce software for monitoring the Controlled Environment Areas (CEAs) at the Empalme, Mexico manufacturing facility.