PMA P010012S347
- Device
- VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S347
- Product code
- LWP
- Decision date
- 2014-05-02
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.
Current openFDA PMA Record#
- Device
- VENTAK CD, CONTAK RENEWAL, LIVIAN, COGNIS, INCEPTA, ENERGEN, PUNCTUA FAMILIES OF CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S347
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-05-02
- Decision code
- APPR
- Date received
- 2014-02-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL TO ADD THE USE OF MINERAL OIL TO DEVICE LABELING.