ENDOTAK C LEAD, SQ PATCH LEAD, SQ LEAD ARRAY, DSP LEAD
FDA premarket approval P910073/S024 · decided 1998-08-13
Approval details
- PMA number
- P910073
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- 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
- 1998-02-19
- Decision date
- 1998-08-13
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for a design change to provide higher pacing impedance. Teh device, as modified, will be marketed under the trade name ENDOTAK(R) Endurance(TM) Endocardial Defibrillation Lead and is indicated for use to provide pacing and rate-sensing and delivery cardioversiona nd defibrillation shocks for AICD automatic implantable cardioverter defibrillator systems.
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