ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
FDA premarket approval P910073/S020 · decided 1996-05-15
Approval details
- PMA number
- P910073
- Supplement
- S020
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-05-10
- Decision date
- 1996-05-15
- Days to decision
- 5 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR THE ENDOTAK C LEAD (MODELS 0060, 0062, 0064, 0065, 0066, 0067, AND 0068), ENDOTAK SQ PATCH LEAD (MODEL 0047 AND 0063), ENDOTAK C LEAD (MODELS 0070, 0072, 0073, 0074, 0075, 0113, AND 0115), ENDOTAK SQ LEAD ARRAY (MODELS 0048 AND 0049), AND ENDOTAK DSP LEAD (MODELS 0092, 0093, 0094, 0095, 0096, 0097, 0123, AND 0125), WHICH REQUESTED APPROVAL TO ADD A PATIENT GROUP TO THE INDICATIONS FOR USE
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