SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947
FDA premarket approval P920015/S049 · decided 2008-11-26
Approval details
- PMA number
- P920015
- Supplement
- S049
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SPRINT QUATTRO SECURE LEADS MODELS 6935 & 6947
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2008-10-27
- Decision date
- 2008-11-26
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- MODIFICATION TO THE SLEEVE HEAD BONDING PROCESS AND TO THE ADHESIVE DAB APPLICATION TO THE OVERLAY TUBING SLIT PROCESS.
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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