PMA P010012S376
- Device
- NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S376
- Product code
- LWP
- Decision date
- 2015-01-29
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR IMPROVEMENTS AND MODIFICATIONS TO THE NG3 AND PROGENY ICD AND CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- NG3 FAMILY OF CRT-D'S (ORIGEN, INOGEN, & DYNAGEN); PROGENY FAMILY OF CRT-D'S (INCEPTA, ENERGEN, & PUNCTUA)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S376
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2015-01-29
- Decision code
- APPR
- Date received
- 2014-10-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR IMPROVEMENTS AND MODIFICATIONS TO THE NG3 AND PROGENY ICD AND CRT-D DEVICES.