PMA P010012S328
- Device
- PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S328
- Product code
- LWP
- Decision date
- 2013-04-30
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- AUTOMATION OF THE EXISTING PROCESS FOR THE FEEDTHRU WELD LEAK TEST.
Current openFDA PMA Record#
- Device
- PUNCTUA, COGNIS, ENERGEN, INCEPTA CRT-D'S
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S328
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2013-04-30
- Decision code
- OK30
- Date received
- 2013-04-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- AUTOMATION OF THE EXISTING PROCESS FOR THE FEEDTHRU WELD LEAK TEST.