PMA P010012S364
- Device
- DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S364
- Product code
- LWP
- Decision date
- 2014-07-28
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- BLISTER SEALER PROCESS SETTING CHANGES FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- DYNAGEN CRT-D, X4 CRT-D, INOGEN CRT-D, X4CRT-D, OGIGEN CRT-D. X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S364
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-07-28
- Decision code
- OK30
- Date received
- 2014-07-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- BLISTER SEALER PROCESS SETTING CHANGES FOR THE DEVICES.