PMA P010012S203
- Device
- COGNIS & LIVIAN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S203
- Product code
- LWP
- Decision date
- 2009-03-18
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order 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.
Current openFDA PMA Record#
- Device
- COGNIS & LIVIAN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S203
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2009-03-18
- Decision code
- APPR
- Date received
- 2009-02-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.