PMA P950037S096
- Device
- EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S096
- Product code
- NVZ
- Decision date
- 2011-05-26
- Classification
- Pulse Generator, Permanent, Implantable
- Generic name
- Pulse generator, permanent, implantable
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.
Current openFDA PMA Record#
- Device
- EVIA/ENTOVIS/ESTELLA/EFFECTA/ECURO
- Applicant
- Biotronik, Inc.
- PMA number
- P950037
- Supplement
- S096
- Product code
- NVZ
- Generic name
- Pulse generator, permanent, implantable
- Decision date
- 2011-05-26
- Decision code
- APPR
- Date received
- 2011-04-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR AN ADDITIONAL SUPPLIER FOR A SECOND SOURCE OF SILICONES FOR USE IN INJECTION MOLDED PARTS FOR LEADS AND ACCESSORIES, AND SEALING PLUGS IN PGS AND ICDS.