PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
FDA premarket approval N970003 · decided 1999-06-03
Approval details
- PMA number
- N970003
- Trade name
- PULSAR/PULSAR MAX IMPLANTABLE PULSE GENERATOR SYSTEM WITH CONSULT SOFTWARE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 1997-09-08
- Decision date
- 1999-06-03
- Days to decision
- 633 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- APPROVAL FOR YOUR PRODUCT DEVELOPMENT PROTOCOL (PDP) FOR THE:GUIDANT PULSAR MODELS 470, 970, 972, 1172, 1272 PULSE GENERATORS, GUIDANT PULSAR MAX MODELS 1170, 1171, 1270 PULSE GENERATORS, AND GUIDANT CONSULT (MODEL 2890) SOFTWARE.GUIDANT PULSAR/PULSAR MAX SERIES PACEMAKERS ARE INDICATED FOR THE FOLLOWING: SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND. OR THIRD-DEGREE AV BLOCK SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCKSYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIA
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