PMA P960040S319
- Device
- INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S319
- Product code
- LWP
- Decision date
- 2014-07-08
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.
Current openFDA PMA Record#
- Device
- INCEPTA, ENERGEN, PUNCTUA, TELIGEN, VITALITY, DYNAGEN, INOGEN, ORIGEN ICDS
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S319
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2014-07-08
- Decision code
- OK30
- Date received
- 2014-06-09
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- ADD A FUNCTIONALLY EQUIVALENT STERILIZATION CHAMBER; 2) ADD A THIRD ABATOR TO BE USED WITH THE ADDITIONAL STERILIZER; AND 3) INCLUDE STERILIZER CHAMBER ENHANCEMENTS REQUIRED FOR THE EXISTING AND ADDITIONAL STERILIZER CHAMBERS.