PMA P010012S510
- Device
- Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S510
- Product code
- NIK
- Decision date
- 2019-10-29
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.
Current openFDA PMA Record#
- Device
- Cardiac Resynchronization Therapy Defibrillator (CRT-D)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S510
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2019-10-29
- Decision code
- OK30
- Date received
- 2019-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Revert to previously approved controlled environment area specifications for feedthrough component and sputter coating manufacturing lines, eliminate use of booties, and change the hand sanitization method.