ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES
FDA premarket approval P910077/S033 · decided 2000-09-25
Approval details
- PMA number
- P910077
- Supplement
- S033
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENDOTAK SQUARE ARRAY XP SUBCUTANEOUS LEAD, SQUARE PATCH LEAD, EPICARDIAL PATCHES
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2000-08-21
- Decision date
- 2000-09-25
- Days to decision
- 35 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT AN ALTERNATE FACILITY FOR STERILIZATION, PACKAGING AND LABELING AT GUIDANT PUERTO RICO, DORADO, PUERTO RICO.
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