PMA P010012S357
- Device
- DYNAGEN, INOGEN, ORIGEN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S357
- Product code
- LWP
- Decision date
- 2014-06-17
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD THE MODEL SE600 SOLDER PRINT INSPECTION (SPI) SYSTEM AS PART OF THE MANUFACTURE PROCESS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- DYNAGEN, INOGEN, ORIGEN
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S357
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-06-17
- Decision code
- OK30
- Date received
- 2014-05-23
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD THE MODEL SE600 SOLDER PRINT INSPECTION (SPI) SYSTEM AS PART OF THE MANUFACTURE PROCESS FOR THE DEVICES.