PMA P960040S338
- Device
- ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S338
- Product code
- LWP
- Decision date
- 2014-12-19
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- CHANGES TO THE CRYSTAL OSCILLATOR COMPONENT MANUFACTURING PROCESS AT THE CURRENT SUPPLIER.
Current openFDA PMA Record#
- Device
- ORIGEN EL, ORIGEN MINI, DYNAGEN EL , DYNAGEN MINI,INOGEN EL,INOGEN MINI,INCEPTA,ENERGEN,PUNCTUA ICDS
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S338
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-12-19
- Decision code
- OK30
- Date received
- 2014-11-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGES TO THE CRYSTAL OSCILLATOR COMPONENT MANUFACTURING PROCESS AT THE CURRENT SUPPLIER.