PMA P010012S287
- Device
- PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S287
- Product code
- LWP
- Decision date
- 2012-05-03
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL FOR THE LABELING MODIFICATION OF THE DEVICE LONGEVITY TABLES FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- PUNTUA CRT-D , COGNIS, ENERGEN & INCEPTA CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S287
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2012-05-03
- Decision code
- APPR
- Date received
- 2012-03-30
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE LABELING MODIFICATION OF THE DEVICE LONGEVITY TABLES FOR THE DEVICES.