STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS
FDA premarket approval P070008/S016 · decided 2010-07-30
Approval details
- PMA number
- P070008
- Supplement
- S016
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- STRATOS LV/LV-T CRT-P; COROX OTW (-S) BP & PTW-L BP LEADS
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Applicant
- Biotronik, Inc.
- Date received
- 2010-05-28
- Decision date
- 2010-07-30
- Days to decision
- 63 days
- Decision code
- APPR
- Product code
- NKE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Lake Oswego, OR
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT STERIGENICS GERMANY GMBH, WIESBADEN, GERMANY AS AN ALTERNATE STERILIZATION FACILITY. 30-DAY NOTICES (135 DAY SUPPLEMENT WAS NOT REQUIRED) SUMMARY OF PMA ORIGINALS & SUPPLEMENTS APPROVEDORIGINALS: SUPPLEMENTS: SUMMARY OF PMA ORIGINALS UNDER REVIEWTOTAL UNDER REVIEW: TOTAL ACTIVE: TOTAL ON HOLD: NUMBER GREATER THAN 180 DAYS: SUMMARY OF PMA SUPPLEMENTS UNDER REVIEWTOTAL UNDER REVIEW: TOTAL ACTIVE: TOTAL ON HOLD: NUMBER GREATER THAN 180 DAYS: SUMMARY OF A
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510(k) clearances by this applicant
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