RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY
FDA premarket approval P020052/S007 · decided 2010-11-05
Approval details
- PMA number
- P020052
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RESPONSE CV CARDIOVERSION ELECTROPHYSIOLOGY
- Generic name
- System, pacing, temporary, acute, internal atrial defibrillation
- Applicant
- St Jude Medical
- Date received
- 2010-10-07
- Decision date
- 2010-11-05
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MTE
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minnetonka, MN
- Statement
- CHANGES TO THE WIRE-TO-RING AND ANCHOR WIRE BRAZING PROCESS.
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