ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES
FDA premarket approval P910073/S031 · decided 2000-04-11
Approval details
- PMA number
- P910073
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENDOTAK SQ ARRAY XP SUBCUTANEOUS LEAD,SQ PATCH LEAD, EPICARDIAL PATCHES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-01-14
- Decision date
- 2000-04-11
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for an extra lead port to the the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049 and a modified DF-1 terminal of: the ENDOTAK SQ Array XP Subcutaneous Lead Model 0049; ENDOTAK SQ Patch Lead Model 0047; ENDOTAK SQ Array Subcutaneous Lead Model 0049; DF-1 Lead Adapters Models 6833, 6835, 6931 and the Epicardial patches models 0067, 0068, which consists of a shorter terminal pin, a counter bore in the terminal pin and a modified coil transition.
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