PMA P030009S091
- Device
- DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S091
- Product code
- MAF
- Decision date
- 2017-02-22
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Introduce an alternate preconditioning room for the Ethylene Oxide sterilization cycle.
Current openFDA PMA Record#
- Device
- DRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS
- Applicant
- Medtronic, Ireland
- PMA number
- P030009
- Supplement
- S091
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2017-02-22
- Decision code
- OK30
- Date received
- 2017-01-30
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Introduce an alternate preconditioning room for the Ethylene Oxide sterilization cycle.