PMA P110010S014
- Device
- PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S014
- Product code
- NIQ
- Decision date
- 2012-05-30
- Classification
- Coronary Drug-eluting Stent
- Generic name
- Coronary drug-eluting stent
- Approval order statement
- REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.
Current openFDA PMA Record#
- Device
- PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P110010
- Supplement
- S014
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-05-30
- Decision code
- OK30
- Date received
- 2012-05-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF WAIST LENGTH IN-PROCESS INSPECTION STEPS.