BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
FDA premarket approval P830060/S041 · decided 1996-09-20
Approval details
- PMA number
- P830060
- Supplement
- S041
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIPOLAR ENDOCARDIAL LEADS 0012/0013 BIPOLAR ENDOCARDIAL LEADS & POSITIVE FIXATION PROTECTED-HELIX BIPOLAR ENDOCAR. LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1995-12-21
- Decision date
- 1996-09-20
- Days to decision
- 274 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- 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
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