PMA P060008S100
- Device
- Taxus Liberte Monorail And And Over-the-wire Coron
- Applicant
- Boston Scientific Corp.
- PMA number
- P060008
- Supplement
- S100
- Decision date
- 2012-12-11
Current openFDA PMA Record
- Device
- TAXUS LIBERTE MONORAIL AND AND OVER-THE-WIRE CORONARY STENT SYSTEM
- Applicant
- Boston Scientific Corp
- PMA number
- P060008
- Supplement
- S100
- Product code
- NIQ
- Generic name
- Coronary drug-eluting stent
- Decision date
- 2012-12-11
- Decision code
- OK30
- Date received
- 2012-11-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- REMOVAL OF TWO IN-PROCESS INSPECTIONS.