PMA P010012S327
- Device
- INCEPTA,ENERGEN,PUNCTUA,COGNIS CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S327
- Product code
- LWP
- Decision date
- 2013-04-26
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- OPTIMIZATION OF WELD PROCESS PARAMETERS AND REMOVAL OF A WELD INSPECTION CRITERION FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- INCEPTA,ENERGEN,PUNCTUA,COGNIS CRT-DS
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S327
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-04-26
- Decision code
- OK30
- Date received
- 2013-04-01
- Supplement type
- 30-Day Notice
- Approval order statement
- OPTIMIZATION OF WELD PROCESS PARAMETERS AND REMOVAL OF A WELD INSPECTION CRITERION FOR THE DEVICES.