SVC/CS TRANSVENE LEAD
FDA premarket approval P980050/S038 · decided 2008-12-03
Approval details
- PMA number
- P980050
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- SVC/CS TRANSVENE LEAD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Medtronic, Inc.
- Date received
- 2008-11-03
- Decision date
- 2008-12-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Mounds View, MN
- Statement
- USE OF A NEW MODEL AIR SAMPLER.
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