- Device
- EASYTRAK® 2 1S-1 Coronary Venous Steroid-Eluting Bipolar Pace/Sense Lead, EASYTRAK® 3 IS-1 Coronary Venous Steroid-Eluti
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S531
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-01-13
- Decision code
- OK30
- Date received
- 2021-01-11
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add a new supplier of nitrile gloves, Ansell.