PMA P010012S456
- Device
- EASYTRACK 2 Lead, ACUITY Spiral Lead
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S456
- Product code
- NIK
- Decision date
- 2017-06-30
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Implementation of serial number reading stations with optical character recognition equipment and software for use in lead manufacturing.
Current openFDA PMA Record#
- Device
- EASYTRACK 2 Lead, ACUITY Spiral Lead
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S456
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-06-30
- Decision code
- OK30
- Date received
- 2017-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of serial number reading stations with optical character recognition equipment and software for use in lead manufacturing.