VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
FDA premarket approval P910077/S018 · decided 1997-05-06
Approval details
- PMA number
- P910077
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VENTAK PRX AICD,SYSTEM FOR THE RHYTHMLINE TM TRANSTELPHONIC INTERROGATION SYSTEM MINI HC AICD, VENTAK II AICD
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 1996-08-30
- Decision date
- 1997-05-06
- Days to decision
- 249 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR RHYTHMLINE(TM) TRANSTELEPHONIC INTERROGATION SYSTEM WHICH WILL PROVIDE REMOTE INTERROGATION AND DATA RETRIEVAL AND ECG MONITORING OF PATIENTS WITH VENTAK PRX II AND PRX III PULSE GENERATORS.
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