PMA P010012S278
- Device
- COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S278
- Product code
- LWP
- Decision date
- 2012-01-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADDITION OF A NEW SUPPLIER FOR THE ANTENNA SOCK COMPONENT, AND FOR CHANGES TO THE RECEIVING ACCEPTANCE ACTIVITIES.
Current openFDA PMA Record#
- Device
- COGNIS/INCEPTA/ENERGEN/PUNCTUA/LIVIAN CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATOR
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S278
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-01-26
- Decision code
- OK30
- Date received
- 2011-12-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADDITION OF A NEW SUPPLIER FOR THE ANTENNA SOCK COMPONENT, AND FOR CHANGES TO THE RECEIVING ACCEPTANCE ACTIVITIES.