NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S
FDA premarket approval P010012/S366 · decided 2014-08-13
Approval details
- PMA number
- P010012
- Supplement
- S366
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NG3 DEVICES: ORIGEN , INOGEN, &, DYNAGEN CRT-D; PROGENGY DEVICES: PUNCTUA , ENERGEN , & INCEPTA CRT-D'S
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2014-08-06
- Decision date
- 2014-08-13
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD A SECOND-TIER SUPPLIER FOR SILICON-CONTROLLED RECTIFIERS (SCRS) AND ANODE GATED THYRISTORS (AGTS).
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