PMA P010012S481
- Device
- Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN,
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S481
- Product code
- NIK
- Decision date
- 2018-03-12
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Alternate test method system for battery electrolyte inspection.
Current openFDA PMA Record#
- Device
- Implantable Cardiac Resynchronization Therpy Defibrillator (CRT-D): PUNCTUA, ENERGEN, INCEPTA, ORIGEN, INOGEN, DYNAGEN,
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S481
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-03-12
- Decision code
- OK30
- Date received
- 2018-02-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Alternate test method system for battery electrolyte inspection.