PMA P910077S054
- Device
- RENEWAL 3 RF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S054
- Product code
- LWS
- Decision date
- 2005-12-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR THE MODEL 6482 COMMUNICATOR LATITUDE WITH APPLICATION V1.6 AND SYSTEM APPLICATION SOFTWARE (SAS) WITH APPLICATION V1.1.1.
Current openFDA PMA Record#
- Device
- RENEWAL 3 RF ICDS
- Applicant
- Boston Scientific
- PMA number
- P910077
- Supplement
- S054
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-12-02
- Decision code
- APPR
- Date received
- 2005-10-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 6482 COMMUNICATOR LATITUDE WITH APPLICATION V1.6 AND SYSTEM APPLICATION SOFTWARE (SAS) WITH APPLICATION V1.1.1.