PMA P830060S058
- Device
- GUIDANT PULSE GENERATORS
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S058
- Product code
- LWS
- Decision date
- 2005-06-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR ADDITIONAL INSTRUCTION FOR USE FOR FREEING STUCK SETSCREWS USING THE BI-DIRECTIONAL TORQUE WRENCH.
Current openFDA PMA Record#
- Device
- GUIDANT PULSE GENERATORS
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S058
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2005-06-20
- Decision code
- APPR
- Date received
- 2005-05-27
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR ADDITIONAL INSTRUCTION FOR USE FOR FREEING STUCK SETSCREWS USING THE BI-DIRECTIONAL TORQUE WRENCH.