PMA P830060S041
- Device
- BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S041
- Product code
- LWS
- Decision date
- 1996-09-20
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR MODELS 0012/0013 BIPOLAR ENDOCARDIAL LEADS; AND 0014/0015 POSITIVE-FIXATION PROTECTED-HELIX BIPOLAR ENDOCARDIAL LEADS TO BE USED IN CONJUNCTIO WITH AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR (AICD) PULSE GENERATORS
Current openFDA PMA Record#
- Device
- BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
- Applicant
- Boston Scientific
- PMA number
- P830060
- Supplement
- S041
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 1996-09-20
- Decision code
- APPR
- Date received
- 1995-12-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODELS 0012/0013 BIPOLAR ENDOCARDIAL LEADS; AND 0014/0015 POSITIVE-FIXATION PROTECTED-HELIX BIPOLAR ENDOCARDIAL LEADS TO BE USED IN CONJUNCTIO WITH AUTOMATIC IMPLANTABLE CARDIOVETER DEFIBRILLATOR (AICD) PULSE GENERATORS