NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4
FDA premarket approval P010012/S360 · decided 2014-07-11
Approval details
- PMA number
- P010012
- Supplement
- S360
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- NG3 CRT-D, DYNAGEN, DYNAGEN X4, INOGEN, INOGEN X4, ORIGEN, ORIGEN X4
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2014-06-19
- Decision date
- 2014-07-11
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- ADD THE LASER ETCHED SCRATCHES INSPECTION CRITERIA FOR THE DEVICES
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