PMA P010012S372
- Device
- DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S372
- Product code
- LWP
- Decision date
- 2014-10-16
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- VERTICALLY INTEGRATE THE MANUFACTURE OF THE SPRING CONTACTS USED IN THE HEADER COMPONENTS OF THE DEVICES.
Current openFDA PMA Record#
- Device
- DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4 ORIGEN,ORIGEN X4, INCEPTA, ENERGEN, PUNCTUA CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S372
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-10-16
- Decision code
- OK30
- Date received
- 2014-09-17
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- VERTICALLY INTEGRATE THE MANUFACTURE OF THE SPRING CONTACTS USED IN THE HEADER COMPONENTS OF THE DEVICES.