COGNIS & LIVIAN
FDA premarket approval P010012/S203 · decided 2009-03-18
Approval details
- PMA number
- P010012
- Supplement
- S203
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- COGNIS & LIVIAN
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2009-02-18
- Decision date
- 2009-03-18
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE SETSCREW DESIGN, SEAL PLUG DESIGN, LABELING FOR THE TORQUE WRENCH, AND THE MODEL 6628 TORQUE WRENCH ACCESSORY KIT AS A STAND ALONE ACCESSORY.
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