PMA P010012S366
- Device
- NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S366
- Product code
- LWP
- Decision date
- 2014-08-13
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD A SECOND-TIER SUPPLIER FOR SILICON-CONTROLLED RECTIFIERS (SCRS) AND ANODE GATED THYRISTORS (AGTS).
Current openFDA PMA Record#
- Device
- NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S366
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-08-13
- Decision code
- OK30
- Date received
- 2014-08-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A SECOND-TIER SUPPLIER FOR SILICON-CONTROLLED RECTIFIERS (SCRS) AND ANODE GATED THYRISTORS (AGTS).